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Newsgroups: sci.cryonics
Path: spies!sgiblab!zaphod.mps.ohio-state.edu!pacific.mps.ohio-state.edu!linac!att!cbnewse!cbnewsd!att-out!cbnewsl!kqb
From: kqb@cbnewsl.cb.att.com (kevin.q.brown)
Subject: Freezing Damage - Part 1
Organization: AT&T Bell Laboratories
Date: Fri, 4 Dec 1992 17:55:23 GMT
Message-ID: <1992Dec4.175523.9470@cbnewsl.cb.att.com>
References:  <merkle.722467022@manarken> <1992Dec1.204713.17920@cbnewsl.cb.att.com>
X-Crossposted-To: cryonics mailing list
Lines: 321

    ------------------------ Forwarded Message ------------------------

> Date: 03 Dec 92 06:49:03 EST
> From: Paul Wakfer <70023.3041@CompuServe.COM> <- Mike Darwin
> Message-Subject: CRYONICS: Freezing Damage (Darwin) Part 1

Note: This posting is from Mike Darwin

     There  have been several requests for information about the  kind 
of  damage done during cryonic suspension.  In particular, there  have 
been  requests for detailed, objective studies.  As a result  of  this 
interest  I have decided to post a research paper which is now in  the 
(hopefully) final stages of preparation for publication.

     However,  there is a serious shortcoming to this posting,  namely 
that  of  necessity  there can be no accompanying  light  or  electron 
micrographs.   In this case this is a serious handicap,  although  for 
many  readers the micrographs would mean little.  In any event, it  is 
to  be  hoped  that  this  paper  can  be  prepared  for  more  formal 
publication within 6 to 12 months.  Anyone who wishes to assist me  in 
this  capacity  should  feel  free  to  do  so  (the  EM's  and  light 
micrographs need to be captioned and laid out -- a formidable task).

     Many caveats about the validity of this work are contained in its 
closing paragraphs.  However, I would like to add the following:   The 
presence  of  pericapillary  ice holes has  been  verified  by  freeze 
substitution  work done by Dr. Gregory M. Fahy of the Red Cross  Organ 
preservation  lab.  Similarly Dr. Fahy's freeze-substitution work  has 
documented  the presence of massive ice crystals which comprise  about 
60% of the tissue volume.  I gather that Dr. Fahy feels somewhat  more 
optimistic about preservation of neuronal connectivity than I do,  but 
one thing we are both agreed on: our work clearly demonstrates serious 
histogical  disruption  with tears or fractures in  the  brain  tissue 
appearing at approximately 3 to 5 micron intervals.

     I  think  it  is  also  fair  to  say  that  anyone,  layman   or 
neurophysiologist  who  looks at either the pictures in the  study  by 
Darwin,  et  al.,  or  the  pictures  generated  by  Fahy  of  freeze-
substituted  brains (showing massive histological disruption  by  ice) 
will be given pause for thought about the workability of cryonics.

     I have great admiration for Dr. Merkle and his work.  But I would 
also  point out that in the theoretical domain where there is  a  will 
there  is  almost  always a way.  Alas, the  real  world  is  somewhat 
harsher.   We  all  want and need to  believe  very  desperately  that 
cryoinjury  can  and will be reversed.  However, there  is  no  direct 
evidence  of this. The kind of damage my colleagues and I observed  in 
the  study  below is carefully "qualified," to make it  good  science.  
However,  in  this  preamble I am a bit freer and I  can  say  that  I 
believe  that the damage is at least as bad as we saw -- it  would  be 
hard  to  imagine  it being any worse short of  calling  it  a  tissue 
homogenate  --  something  you  get when you run  a  brain  through  a 
blender.   It is my gut feel that post-thaw artifactual  stirring  was 
not the main reason things look bad.  I think things look bad  because 
they *are* bad.  

     Does  that mean patients frozen with today's techniques will  not 
be  revived?  I do not know.  Does that mean we should *not*  continue 
to  freeze people?  No.  What it does mean is that we need to do  some 
serious work to improve the situation.  The kind of damage we observed 
and are observing is a consequence of ice formation.  At a minimum  we 
can  do a great deal to reduce or eliminate ice formation.   A  major, 
comprehensive research proposal is under development at this time  and 
should  be  ready  for submission to the cryonics  community  by  late 
Spring or early Summer.

     In  the  meantime  my colleagues and  I  at  Biopreservation  and 
Cryovita are working hard to make further improvements on  hypothermic 
brain  presevation  which  will  allow us  to  conduct  the  necessary 
cryopreservation work with greater ease.

     Also in order is a word about Jerry Leaf, who entered  suspension 
over  a year ago.  This work was completed in the mid 1980's and  this 
paper  was  completed  in  draft form  circa  1988.   Jerry  read  and 
commented  on the draft shortly after it was written.   Most, but  not 
all  of  his  suggested  changes were  incorporated.   The  final  two 
paragraphs  of  summary  were written after his  suspension.   I  feel 
comfortable that Jerry would want this paper published, warts and all. 
The  work that underpins it took a great deal of his time and  effort.  
Indeed,  while none of us knew it at the time, this work  comprised  a 
major  block of Jerry's cryonics-science productive life.  In  drawing 
the few conclusion I draw, I have striven to be as objective as  Jerry 
would  have  been.  I have also submitted this work for  review  by  a 
prominent   cryonicist-cryobiologist  whom  I  know  Jerry   respected 
greatly.   I have incorporated all of this cryobiologists  substantive 
revisions.

     Finally,  to Jerry: may you someday have the pleasure of  reading 
these  words  and  proving  us both  wrong  about  the  prospects  for 
recovery.  Jerry, I miss you more than words can tell.  

THE EFFECTS OF CRYOPRESERVATION ON THE CAT
by Michael Darwin, Jerry Leaf, Hugh L. Hixon


I.   Introduction                                   
II.  Materials and Methods
III. Effects of Glycerolization
IV.  Gross Effects of Cooling to and Rewarming From -196*C
V.   Effects of Cryopreservation on Histology of Selected Tissues
VI.  Effects of Cryopreservation on Ultrastructure of Selected Tissues
VII. Summary and Discussion


I. INTRODUCTION

     The  immediate  goal  of cryonic suspension  is  to  use  current 
cryobiological  techniques  to  preserve the  brain  structures  which 
encode personal identity adequately enough to allow for  resuscitation 
or reconstruction of the individual should molecular nanotechnology be 
realized (1,2).  Aside from two previous isolated efforts (3,4)  there 
has  been  virtually no systematic effort to examine the  fidelity  of 
histological,  ultrastructural, or even gross structural  preservation 
of  the brain following cryopreservation in either an animal or  human 
model.    While  there  is  a  substantial  amount  of  indirect   and 
fragmentary  evidence  in the  cryobiological  literature  documenting 
varying  degrees  of  structural  preservation  in  a  wide  range  of 
mammalian tissues (5,6,7), there is little data of direct relevance to 
cryonics.   In particular, the focus of contemporary  cryobiology  has 
been   on   developing  cryopreservation  techniques   for   currently 
transplantable  organs,  and this has necessarily  excluded  extensive 
cryobiological  investigation  of  the brain, the  organ  of  critical 
importance to human identity and mentation.

     The  principal  objective of this pilot study was to  survey  the 
effects  of glycerolization, freezing to liquid nitrogen  temperature, 
and  rewarming  on  the physiology, gross  structure,  histology,  and 
ultrastructure of both the ischemic and non-ischemic adult cats  using 
a preparation protocol similar to the one then in use on human cryonic 
suspension patients.  The non-ischemic group was given the designation 
Feline Glycerol Perfusion (FGP) and the ischemic group was referred to 
as Feline Ischemic Glycerol Perfusion (FIGP). 

     The work described in this paper was carried out over a  19-month 
period from January, 1982 through July, 1983.  The perfusate  employed 
in this study was one which was being used in human cryonic suspension 
operations at that time, the composition of which is given in Table I.  
The principal cryoprotectant was glycerol.


II. MATERIALS AND METHODS

Preperfusion Procedures

     Nine adult cats weighing between 3.4 and 6.0 kg were used in this 
study.  The animals were divided evenly into a non-ischemic and a  24-
hour mixed warm/cold ischemic group.  All animals received humane care 
in  compliance  with  the  "Principles  of  Laboratory  Animal   Care" 
formulated by the National Society for Medical Research and the "Guide 
for  the Care and Use of Laboratory Animals" prepared by the  National 
Institutes  of  Health  (NIH Publication  No.  80-23,  revised  1978).  
Anesthesia   in  both  groups  was  secured  by  the   intraperitoneal 
administration of 40 mg/kg of sodium pentobarbital.  The animals  were 
then  intubated and placed on a pressure-cycled respirator.   The  EKG 
was monitored throughout the procedure until cardiac arrest  occurred.  
Rectal and esophageal temperatures were continuously monitored  during 
perfusion using YSI type 401 thermistor probes.    

     Following placement of temperature probes, an IV was  established 
in  the medial foreleg vein and a drip of Lactated Ringer's was  begun 
to  maintain  the  patency of the IV and  support  circulating  volume 
during  surgergy. Premedication (prior to perfusion) consisted of  the 
IV  administration of 1 mg/kg of metubine iodide to inhibit  shivering 
during  external  and  extracorporeal cooling  and  420  IU/kg  sodium 
heparin  as  an anticoagulent.  Two 0.77 mm I.D.  Argyle  Medicut  15" 
Sentinel line catheters with Pharmaseal K-69 stopcocks attached to the 
luer fittings of the catheters were placed in the right femoral artery 
and vein.  The catheters were connected to Gould Model P23Db  pressure 
transducers   and  arterial  and  venous  pressures   were   monitored 
throughout the course of perfusion.


Surgical Protocol

     Following placement of the monitoring catheters, the animals were 
transferred  to a tub of crushed ice and positioned for surgery.   The 
chest  was shaved and a median sternotomy was performed.   The  aortic 
root was cleared of fat and a purse-string suture was placed,  through 
which  a  14-gauge  angiocath was introduced.   The  angiocath,  which 
served  as  the  arterial  perfusion cannula,  was  snared  in  place, 
connected  to  the  extracorporeal circuit and cleared  of  air.   The 
pericardium  was  opened  and tented to expose the  right  atrium.   A 
purse-string  suture was placed in the apex of the right atrium and  a 
USCI  type  1967 16 fr. venous cannula was introduced  and  snared  in 
place.  Backties were used on both the arterial and venous cannulae to 
secure  them and prevent accidental dislodgment during the  course  of 
perfusion.  Placement of cannulae is shown in Figure 2.


Extracorporeal Circuit

     The extracorporeal circuit (Figure 3) was of composed of 1/4" and 
3/8"  medical grade polyvinyl chloride tubing.  The circuit  consisted 
of  two  sections:  a  recirculating loop  to  which  the  animal  was 
connected  and a glycerol addition system.  The  recirculating  system 
consisted  of  a  10 liter polyethylene reservoir  positioned  atop  a 
magnetic  stirrer, an arterial (recirculating) roller pump,  an  Erika 
HPF-200  hemodialyzer which was used as a hollow fiber oxygenator  (8) 
(or alternatively, a Sci-Med Kolobow membrane oxygenator), a  Travenol 
Miniprime  pediatric  heat  exchanger, and a 40-micron  Pall  LP  1440 
pediatric blood filter.  The recirculating reservoir was  continuously 
stirred with a 2" teflon-coated magnetic stir bar driven by a  Corning 
PC  353 magnetic stirrer.  Temperature was continuously  monitored  in 
the  arterial line approximately six inches from the arterial  cannula 
using a Sarns in-line thermistor temperature probe and YSI 42SL remote 
sensing  thermometer.  Glycerol concentrate was continuously added  to 
the the recirculating system using a Drake-Willock hemodialysis pump.  


Storage and Reuse of the Extracorporeal Circuit

     After  use the circuit was flushed extensively with filtered  tap 
and distilled water, and then flushed and filled with 3%  formaldehyde 
in distilled water to prevent bacterial overgrowth.  Prior to use  the 
circuit was again thoroughly flushed with filtered tap water, and then 
with  filtered distilled water (including both blood and gas sides  of 
the hollow fiber dialyzer; Kolobow oxygenators were not re-used).   At 
the  end  of  the distilled water flush, a test for  the  presence  of 
residual formaldehyde was performed using Schiff's Reagent.  Prior  to 
loading  of  the perfusate, the circuit was rinsed with 10  liters  of 
clinical  grade normal saline to remove any particulates  and  prevent 
osmotic dilution of the base perfusate.

     Pall filters and arterial cannula were not re-used.  The  circuit 
was replaced after a maximum of three uses.


Preparation of Control Animals

Fixative Perfused

     Two control animals were prepared as per the above.  However, the 
animals  were subjected to fixation after induction of anesthesia  and 
placement  of cannulae.  Fixation was achieved by first perfusing  the 
animals   with  500  cc  of  bicarbonate-buffered  Lactated   Ringer's 
containing 50 g/l hydroxyethyl starch (HES) with an average  molecular 
weight  of  400,000 to 500,000 supplied by  McGaw  Pharmaceuticals  of 
Irvine, Ca (pH adjusted to 7.4) to displace blood and facilitate  good 
distribution of fixative, followed immediately by perfusion of 1 liter 
of  modified  Karnovsky's  fixative (Composition given  in  Table  I).  
Buffered Ringers-HES perfusate and Karnovsky's solution were  filtered 
through 0.2 micron filters and delivered with the same  extracorporeal 
circuit described above.  

     Immediately   following  fixative  perfusion  the  animals   were 
dissected and 4-5 mm thick coronal sections of organs were cut, placed 
in  glass screw-cap bottles, and transported, as detailed  below,  for 
light or electron microscopy.


Straight Frozen Non-ischemic Control

     One animal was subjected to straight freezing (i.e., not  treated 
with   cryoprotectant).    Following  induction  of   anesthesia   and 
intubation  the  animal  was supported on  a  respirator  while  being 
externally  cooled  in  a  crushed  ice-water  bath.   When  the   EKG 
documented  profound bradycardia at 26*C, the animal was  disconnected 
from  the  respirator,  placed  in a  plastic  bag,  submerged  in  an 
isopropanol  cooling bath at -10*C, and chilled to dry ice and  liquid 
nitrogen  temperature  per the same protocol used for  the  other  two 
experimental groups as described below.


Preparation of FGP Animals

     Following  placement of cannulae, FGP animals were  subjected  to 
total  body  washout  (TBW) by open-circuit perfusion  of  500  cc  of 
glycerol-free  perfusate.  The extracorporeal circuit was then  closed 
and constant-rate addition of glycerol-containing perfusate was begun.  
Cryoprotective  perfusion continued until the target concentration  of 
glycerol  was reached or the supply of glycerol-concentrate  perfusate 
was exhausted.
     

Preparation of FIGP Animals

     In   the  FIGP  animals,  respirator  support  was   discontinued 
following anasthesia and administration of Metubine.  The endotracheal 
tube was clamped and the ischemic episode was considered to have begun 
when cardiac arrest was documented by absent EKG.

     After the start of the ischemic episode the animals were  allowed 
to  remain on the operating table at room temperature ( 22*C to  25*C) 
for  a  30  minute period to simulate  the  typical  interval  between 
pronouncement  of legal death in a clinical environment and the  start 
of  external cooling at that time.  During the 30 minute  normothermic 
ischemic  interval the femoral cut-down was performed  and  monitoring 
lines were placed in the right femoral artery and vein as per the  FGP 
animals.  Prior to placement, the monitoring catheters were  irrigated 
with normal saline, and following placement the catheters were  filled 
with 1000 unit/cc of sodium heparin to guard against clot  obstruction 
of the catheter during the post-mortem ischemic period.

     After the 30 minute normothermic ischemic period the animals were 
placed  in  a  1-mil polyethylene bag,  transferred  to  an  insulated 
container  in  which  a bed of crushed ice had  been  laid  down,  and 
covered  over with ice.  A typical cooling curve for a FIGP animal  is 
presented in Figure 1. FIGP animals were stored on ice in this fashion 
for a period of 24 hours, after which time they were removed from  the 
container and prepared for perfusion using the surgical and  perfusion 
protocol described above.


Perfusate

     The  perfusate  was an intracellular formulation  which  employed 
sodium  glycerophosphate  as the impermeant species  and  hydroxyethyl 
starch  (HES)(av.  MW   400,000  -  500,000)  as  the  colloid.    The 
composition of the base perfusate is given in Table I.  The pH of  the 
perfusate  was adjusted to 7.6 with potassium hydroxide.  A  pH  above 
7.7, which would have been "appropriate" to the degree of  hypothermia 
experienced  during cryoprotective perfusion (9), was  not  achievable 
with  this mixture owing to problems with complexing of magnesium  and 
calcium   with  the  phosphate  buffer,  resulting  in  an   insoluble 
precipitate.  

     Perfusate components were reagent or USP grade and were dissolved 
in USP grade water for injection.  Perfusate was prefiltered through a 
Whatman GFB glass filter (a necessary step to remove precipitate)  and 
then passed through a Pall 0.2 micron filter prior to loading into the 
extracorporeal circuit.


Perfusion

     Perfusion  of both groups of animals was begun by carrying out  a 
total body washout (TBW) with the base perfusate in the absence of any 
cryoprotective agent.  In the FGP group washout was achieved within  2 
-  3 minutes of the start of open circuit asanguineous perfusion at  a 
flow rate of 160 to 200 cc/min and an average perfusion pressure of 40 
mmHg.   TBW  in  the  FGP  group  was  considered  complete  when  the 
hematocrit  was  unreadable and the venous effluent was  clear.   This 
typically was achieved after perfusion of 500 cc of perfusate. 

     Complete blood washout in the FIGP group was virtually impossible 
to  achieve (see "Results" below).  A decision was made prior  to  the 
start  of  this  study (based on  previous  clinical  experience  with 
ischemic human cryonic suspension patients) not to allow the  arterial 
pressure  to  exceed  60  mmHg for any  significant  period  of  time.  
Consequently, peak flow rates obtained during both total body  washout 
and subsequent glycerol perfusion in the FIGP group were in the  range 
of 50-60 cc/min at a mean arterial pressure of 50 mmHg.

     Due to the presence of massive intravascular clotting in the FIGP 
animals  it  was necessary to delay placement of the  atrial  (venous) 
cannula (lest the drainage holes become plugged with clots) until  the 
large  clots present in the right heart and the superior and  inferior 
vena  cava  had been expressed through the atriotomy.  The  chest  was 
kept  relatively  clear of fluid/clots by active suction  during  this 
interval.   Removal  of  large clots and reasonable  clearing  of  the 
effluent  was usually achieved in the FIGP group after 15  minutes  of 
open  circuit asanguineous perfusion, following which the circuit  was 
closed and the introduction of glycerol was begun.

     The  arterial pO2 of animals in both the FGP and FIGP groups  was 
kept  between  600  mmHg and 760 mmHg throughout  TBW  and  subsequent 
glycerol  perfusion.  Arterial pH in the FGP animals was  between  7.1 
and  7.7  and was largely a function of the degree of  diligence  with 
which  addition of buffer was pursued.  Arterial pH in the FIGP  group 
was 6.5 to 7.3.  Two of the FIGP animals were not subjected to  active 
buffering during perfusion and as a consequence recovery of pH to more 
normal  values  from the acidosis of ischemia (starting  pH  for  FIGP 
animals was typically 6.5 to 6.6) was not as pronounced.

     Introduction  of glycerol was by constant rate addition  of  base 
perfusate  formulation  made up with 6M glycerol  to  a  recirculating 
reservoir  containing 3 liters of glycerol-free base  perfusate.   The 
target  terminal tissue glycerol concentration was 3M and  the  target 
time  course for introduction was 2 hours.  The volume of 6M  glycerol 
concentrate  required  to  reach  a  terminal  concentration  in   the 
recirculating   system  (and  thus  presumably  in  the  animal)   was 
calculated as follows:

             Vp
     Mc = --------- Mp
           Vc + Vp


where

     Mc = Molarity of glycerol in animal and circuit.

     Mp = Molarity of glycerol concentrate.

     Vc = Volume of circuit and exchangeable volume of animal.*

     Vp = Volume of perfusate added.

     * Assumes an exchangeable water volume of 60% of the preperfusion      
weight of the animal.

     Glycerolization  of  the FGP animals was carried out at  10*C  to 
12*C.   Initial  perfusion  of FIGP animals was at  4*C  to  5*C  with 
warming  (facilitated  by  TBW with warmer perfusate  and  removal  of 
surface  ice packs) to 10*-12*C for cryoprotectant introduction.   The 
lower  TBW  temperature of the FIGP animals was a consequence  of  the 
animals  having  been refrigerated on ice for the 24  hours  preceding 
perfusion.

     Following  termination  of the cryoprotective ramp,  the  animals 
were  removed  from bypass, the aortic cannula was left  in  place  to 
facilitate  prompt reperfusion upon rewarming, and the venous  cannula 
was removed and the right atrium closed.  The chest wound was  loosely 
closed using surgical staples.

     Concurrent with closure of the chest wound, a burrhole craniotomy 
3  to  5  mm in diameter was made in the right parietal  bone  of  all 
animals  using a high speed Dremel "hobby" drill.  The purpose of  the 
burrhole  was  to  allow for  post-perfusion  evaluation  of  cerebral 
volume, assess the degree of blood washout in the ischemic animals and 
facilitate  rapid expansion of the burrhole on rewarming to allow  for 
the visual evaluation of post-thaw reperfusion (using dye).  

     The  rectal  thermistor probe used to  monitor  core  temperature 
during  perfusion was replaced by a copper/constantan thermocouple  at 
the  conclusion  of perfusion for monitoring of the  core  temperature 
during cooling to -79*C and -196*C.


Cooling to -79*C

     Cooling  to -79*C was carried out by placing the  animals  within 
two 1 mil polyethylene bags and submerging them in an isopropanol bath 
which  had  been  precooled to -10*C.   Bath  temperature  was  slowly 
reduced  to  -79*C  by the periodic addition of dry  ice.   A  typical 
cooling curve obtained in this fashion is shown in Figure 5.   Cooling 
was at a rate of approximately 4*C per hour.


Cooling to and Storage at -196*C

     Following cooling to -79*C, the plastic bags used to protect  the 
animals  from  alcohol were removed, the animals  were  placed  inside 
nylon  bags with draw-string closures and were then positioned atop  a 
6" high aluminum platform in an MVE TA-60 cryogenic dewar to which 2"-
3" of liquid nitrogen had been added.  Over a period of  approximately 
48  hours  the liquid nitrogen level was gradually  raised  until  the 
animal  was  submerged.  A typical cooling curve  to  liquid  nitrogen 
temperature  for animals in this study is shown in Figure 6.   Cooling 
rates to liquid nitrogen temperature were approximately 2*C per  hour.  
After  cool-down  animals  were maintained in liquid  nitrogen  for  a 
period  of  6-8  months until being removed  and  rewarmed  for  gross 
structural, histological, and ultrastructural evaluation.

Rewarming

     The  animals  in  both groups were rewarmed to -2*C  to  -3*C  by 
removing them from liquid nitrogen and placing them in a precooled box 
insulated on all sides with a 2" thickness of styrofoam and containing 
a small quantity of liquid nitrogen.  The animals were then allowed to 
rewarm to approximately -20*C, at which time they were transferred  to 
a  mechanical  refrigerator at a temperature of 8*C.   When  the  core 
temperature  of the animals had reached -2*C to -3*C the animals  were 
removed to a bed of crushed ice for post-mortem examination and tissue 
collection  for  light and electron microscopy.  A  typical  rewarming 
curve is presented in Figure 7.


Modification of Protocol Due To Tissue Fracturing

     After the completion of the first phase of this study  (perfusion 
and  cooling  to  liquid nitrogen temperature)  the  authors  had  the 
opportunity  to evaluate the gross and histological condition  of  the 
remains  of three human cryonic suspension patients who  were  removed 
from  cryogenic  storage  and  converted  to  neuropreservation  (thus 
allowing  for post-mortem dissection of the body, excluding the  head) 
(10).  The results of this study confirmed previous, preliminary, data 
indicative of gross fracturing of organs and tissues in animals cooled 
to  and  rewarmed from -196*C.  These findings led us to  abandon  our 
plans  to  reperfuse  the  animals  in  this  study  with  oxygenated, 
substrate-containing  perfusate  (to have been  followed  by  fixative 
perfusion  for histological and ultrastructural evaluation) which  was 
to be have been undertaken in an attempt to assess post-thaw viability 
by  evaluation  of post-thaw oxygen consumption, glucose  uptake,  and 
tissue-specific enzyme release.

     Rewarming  and  examination  of the first  animal  in  the  study 
confirmed  the presence of gross fractures in all organ systems.   The 
scope  and severity of these fractures resulted in disruption  of  the 
circulatory system, thus precluding any attempt at reperfusion as  was 
originally planned.


Preparation of Tissue Samples For Microscopy

Fixation

     Samples of four organs were collected for subsequent histological 
and  ultrastructural  examination:  brain, heart,  liver  and  kidney.  
Dissection  to  obtain  the tissue samples was begun as  soon  as  the 
animals  were  transferred to crushed ice.  The brain  was  the  first 
organ  removed  for sampling.  The burrhole created at  the  start  of 
perfusion  was  rapidly extended to a full craniotomy  using  rongeurs 
(Figure  8).   The  brain was then removed en bloc to  a  shallow  pan 
containing  iced,  modified Karnovsky's fixative  containing  25%  w/v 
glycerol  (see  Table  I  for composition)  sufficient  to  cover  it.  
Slicing of the brain into 5 mm thick sections was carried out with the 
brain  submerged  in fixative in this manner.  At  the  conclusion  of 
slicing  a 1 mm section of tissue was excised from the  visual  cortex 
and  fixed  in a separate container for electron  microscopy.   During 
final  sample  preparation for electron microscopy care was  taken  to 
avoid  the  cut  edgdes  of the tissue block  in  preparing  the  Epon 
embedded sections.

     The  sliced  brain  was  then placed in  350  ml  of  Karnovsky's 
containing  25%w/v glycerol in a special stirring apparatus  which  is 
illustrated  in Figure 9.  This  fixation/deglycerolization  apparatus 
consisted of two plastic containers nested inside of each other atop a 
magnetic stirrer.  The inner container was perforated with numerous  3 
mm holes and acted to protect the brain slices from the stir bar which 
continuously  circulated the fixative over the slices.   The  stirring 
reduced  the likelihood of delayed or poor fixation due to overlap  of 
slices  or stable zones of tissue water stratification.   (The  latter 
was a very real possibility owing to the high viscosity of the  25%w/v 
glycerol-containing Karnovsky's.)


Deglycerolization of Samples 
     
     To avoid osmotic shock all tissue samples were initially immersed 
in Karnovsky's containing 25%w/v glycerol at room temperature and were 
subsequently  deglycerolized  prior  to  staining  and  embedding   by 
stepwise    incubation    in   Karnovsky's    containing    decreasing 
concentrations  of  glycerol  (see  Figure  10  for  deglycerolization 
protocol).  

     To  prepare  tissue sections from heart, liver,  and  kidney  for 
microscopy,  the  organs  were  first removed  en  bloc  to  a  beaker 
containing an amount of ice-cold fixative containing 25% w/v  glycerol 
sufficient  to cover the organ.  The organ was then removed to a  room 
temperature  work  surface at where 0.5 mm sections were made  with  a 
Stadie-Riggs microtome.  The microtome and blade were pre-wetted  with 
fixative,  and cut sections were irrigated from the microtome  chamber 
into  a beaker containing 200 ml of room-temperature fixative using  a 
plastic  squeeze-type  laboratory  rinse  bottle  containing  fixative 
solution.   Sections  were  deglycerolized using  the  same  procedure 
previously detailed for the other slices. 


Osmication and Further Processing

     At  the  conclusion  of deglycerolization of  the  specimens  all 
tissues  were  separated into two groups; tissues to be  evaluated  by 
light microscopy, and those to be examined with transmission  electron 
microscopy.   Tissues for light microscopy were shipped  in  glycerol-
free  modified  Karnovsky's solution to American  Histolabs,  Inc.  in 
Rockville,  MD  for  paraffin  embedding,  sectioning,  mounting,  and 
staining.

     Tissues   for  electron  microscopy  were  transported   to   the 
facilities  of the University of California at San Diego in  glycerol-
free  Karnovsky's at 1* to 2*C for osmication, Epon embedding, and  EM 
preparation of micrographs by Dr. Paul Farnsworth.

     Due  to  concerns  about the osmication and  preparation  of  the 
material processed for electron microscopy by Farnsworth, tissues from 
the  same  animals  were also submitted  for  electron  microscopy  to 
Electronucleonics of Silver Spring, Maryland.


investigator  has yet to provide the necessary information and  we  do 
not have access to the pictures. 


III. EFFECTS OF GLYCEROLIZATION

Perfusion of FGP Animals 

     Blood  washout  was  rapid and complete in the  FGP  animals  and 
vascular  resistance  decreased  markedly  following  blood   washout.  
Vascular  resistance increased steadily as the glycerol  concentration 
increased,  probably  as a result of the increasing viscosity  of  the 
perfusate.

     Within   approximately  5  minutes  of  the  beginning   of   the 
cryoprotective ramp, bilateral ocular flaccidity was noted in the  FGP 
animals.   As  the perfusion proceeded, ocular  flaccidity  progressed 
until  the  eyes had lost approximately 30% to 50%  of  their  volume.  
Gross  examination  of the eyes revealed that initial water  loss  was 
primarily  from the aqueous humor, with more significant  losses  from 
the posterior chamber of the eyes apparently not occurring until later 
in  the  course  of  perfusion.  Within 15 minutes  of  the  start  of 
glycerolization  the corneal surface became dimpled and irregular  and 
the eyes had developed a "caved-in" appearance.

     Dehydration  was also apparent in the skin and  skeletal  muscles 
and  was  evidenced  by  a marked decrease  in  limb  girth,  profound 
muscular  rigidity,  cutaneous  wrinkling (Figure 11),  and  a  "waxy-
leathery" appearance and texture to both cut skin and skeletal muscle.  
Tissue water evaluations conducted on ileum, kidney, liver, lung,  and 
skeletal  muscle  confirmed  and  extended  the  gross   observations.   
Preliminary  observation suggest that water loss was in the  range  of 
30%  to 40% in most tissues. As can be seen in Table III,  total  body 
water  losses  attributable  to dehydration, while  typically  not  as 
profound, were still in the range of 18% to 34%.  The gross appearance 
of  the heart suggested a similar degree of dehydration, as  evidenced 
by modest shrinkage and the development of a "pebbly" surface  texture 
and a somewhat translucent or "waxy" appearance.

     Examination  of  the cerebral hemispheres through the  burr  hole 
(Figure  12)  revealed an estimated 30% to 50% reduction  in  cerebral 
volume,  presumably  as a result of osmotic dehydration  secondary  to 
glycerolization.   The cortices also had the "waxy"  amber  appearance 
previously observed as characteristic of glycerolized brains.

     The  gross  appearance  of the kidneys,  spleen,  mesenteric  and 
subcutaneous  fat, pancreas, and reproductive organs  (where  present) 
were   unremarkable.   The  ileum  and  mesentery  appeared   somewhat 
dehydrated,  but  did  not  exhibit  the  waxy  appearance  that   was 
characteristic of muscle, skin, and brain.

     Oxygen  consumption (determined by measuring the  arterial/venois 
difference)  throughout  perfusion  was fairly constant  and  did  not 
appear to be significantly impacted by glycerolization, as can be seen 
Figure 12.


Perfusion of FIGP Animals

     As previously noted, the ischemic animals had far lower flowrates 
at  the  same  perfusion  pressure as  FGP  animals  and  demonstrated 
incomplete  blood  washout.   Intravascular  clotting  was  serious  a 
barrier  to  adequate perfusion.   Post-thaw  dissection  demonstrated 
multiple  infarcted areas in virtually all organ systems; areas  where 
blood  washout  and  glycerolization were incomplete  or  absent.   In 
contrast  to  the even color and texture changes observed in  the  FGP 
animals,  the  skin of the FIGP animals  developed  multiple,  patchy, 
nonperfused   areas  which  were  clearly  outlined  by   surrounding, 
dehydrated, amber-colored glycerolized areas.  

     External  and internal examination of the brain and  spinal  cord 
revealed  surprisingly  good  blood washout  of  the  central  nervous 
system.  While grossly visible infarcted areas were noted, these  were 
relatively  few  and  were generally no larger than 2 mm to  3  mm  in 
diameter.   With few exceptions, the pial vessels were free  of  blood 
and appeared empty of gross emboli.  One striking difference which was 
consistently  observed  in  FIGP  animals  was  a  far  less  profound 
reduction  in brain volume during glycerolization (Figure  13).   This 
may  have  been due to a number of factors: lower flow  rates,  higher 
perfusion  pressures,  and the increased  capillary  permeability  and 
perhaps increased cellular permeability to glycerol.  

     Whereas   edema   was   virtually   never   a   problem    during 
glycerolization  of  FGP  animals, edema was  universal  in  the  FIGP 
animals  after as little as 30 minutes of perfusion.  In  the  central 
nervous  system this edema was evidenced by a "rebound"  from  initial 
cerebral  shrinkage  to  frank  cerebral  edema,  with  the  cortices, 
restrained by the dura, often abutting or slightly projecting into the 
burrhole.   Marked  edema of the nictating membranes,  the  lung,  the 
intestines,  and  the  pancreas  was also a  uniform  finding  at  the 
conclusion  of cryoprotective perfusion.  The development of edema  in 
the central nervous system sometimes closely paralleled the  beginning 
of "rebound" of ocular volume and the development of ocular turgor and 
frank ocular edema.  

     In contrast to the relatively good blood washout observed in  the 
brain,  the  kidneys  of  FIGP animals had a  very  dark  and  mottled 
appearance.   While  some  areas (an estimated  20%  of  the  cortical 
surface) appeared to be blood-free, most of the organ remained  blood-
filled throughout perfusion.  Smears of vascular fluid made from renal 
biopsies  which  were collected at the conclusion  of  perfusion  (for 
tissue  water determinations) revealed the presence of many  free  and 
irregularly clumped groups of crenated and normal-appearing red cells, 
further evidence of the incompleteness of blood washout.   Microscopic 
examination  of recirculating perfusate revealed some free, and a  few 
clumped  red  cells.   However, the concentration  was  low,  and  the 
perfusate  microhematocrit  was  unreadable  at  the  termination   of 
perfusion (i.e., less than 1%).

     The  liver  of  FIGP  animals  appeared  uniformly   blood-filled 
throughout  perfusion,  and  did not exhibit even  the  partial  blood 
washout evidenced by the kidneys.  However, despite the absence of any 
grossly  apparent blood washout, tissue water evaluations in one  FIGP 
animal  were  indicative  of  osmotic dehydration  and  thus  of  some 
perfusion.

     The mesenteric, pancreatic, splanchic, and other small  abdominal 
vessels  were  largely free of blood by the conclusion  of  perfusion.  
However,  blood-filled  vessels  were not  uncommon,  and  examination 
during   perfusion   of   mesenteric   vessels   performed   with   an 
ophthalmoscope  at 20X magnification revealed stasis in  many  smaller 
vessels, and irregularly shaped small clots or agglutinated masses  of 
red  cells in most of the mesenteric vessels.   Nevertheless,  despite 
the   presence  of  massive  intravascular  clotting,  perfusion   was 
possible, and significant amounts of tissue water appear to have  been 
exchanged for glycerol.

     One  immediately  apparent difference between the  FGP  and  FIGP 
animals  was  the  accumulation in the lumen of  the  ileum  of  large 
amounts  of  perfusate  or perfusate  ultrafiltrate  by  the  ischemic 
animals.  Within approximately 10 minutes of the start of reperfusion, 
the  ileum  of the ischemic animals that had  been  laparotomized  was 
noticed  to  be  accumulating fluid.  By the  end  of  perfusion,  the 
stomach  and the small and large bowel had become massively  distended 
with  perfusate.   Figure  14 shows both FIGP and  FGP  ileum  at  the 
conclusion  of glycerol perfusion.  As can be clearly seen,  the  FIGP 
intestine  is markedly distended.  Gross examination of the  gut  wall 
was   indicative  of  tissue-wall  edema  as  well   as   intraluminal 
accumulation  of  fluid.  Often by the end of perfusion, the  gut  had 
become  so  edematous  and  distended  with  perfusate  that  it   was 
impossible  to completely close the laparotomy  incision.   Similarly, 
gross  examination of gastric mucosa revealed severe erosion with  the 
mucosa being very friable and frankly hemorrhagic.

     Escape  of  perfusate/stomach contents from the  mouth  (purging) 
which occurs during perfusion in ischemically injured human suspension 
patients did not occur, perhaps due to greater post-mortem  competence 
of the gastroesophageal valve in the cat.

     Oxygen  consumption  in  the two ischemic cats in  which  it  was 
measured  was dramatically impacted, being only 30% to 50% of  control 
and deteriorating throughout the course of perfusion (Figure 12).


IV. GROSS EFFECTS OF COOLING TO AND REWARMING FROM -196*C

     The  most striking change noted upon thawing of the  animals  was 
the presence of multiple fractures in all organ systems.  As had  been 
previously noted in human cryonic suspension patients, fracturing  was 
most pronounced in delicate, high flow organs which are poorly  fiber-
reinforced.   An exception to this was the large arteries such as  the 
aorta, which were heavily fractured.

     Fractures  were most serious in the brain, spleen, pancreas,  and 
kidney.   In these organs fractures would often completely  divide  or 
sever  the  organ  into one or more discrete  pieces.   Tougher,  more 
fiber-reinforced tissues such as myocardium, skeletal muscle, and skin 
were less affected by fracturing; there were fewer fractures and  they 
were smaller and less frequently penetrated the full thickness of  the 
organ.

     In both FGP and FIGP animals the brain was particularly  affected 
by  fracturing  and  it  was not uncommon to  find  fractures  in  the 
cerebral hemispheres penetrating through to the ventricles as seen  in 
Figure  15, or to find most of both cerebral hemispheres and the  mid-
brain  completely  severed from the cerebellum by a  fracture  (Figure 
16).  Similarly, the cerebellum was uniformly severed from the medulla 
at the foramen magnum as were the olfactory lobes, which were  usually 
retained  within  the olfactory fossa with severing  fractures  having 
occurred at about the level of the transverse ridge.  The spinal  cord 
was  invariably transversely fractured at intervals of 5 mm to  15  mm 
over  its  entire  length.  Bisecting CNS fractures  were  most  often 
observed  to  occur  transversely  rather  than  longitudinally.    In 
general,  roughly  cylindrical structures such as  arteries,  cerebral 
hemispheres, spinal cord, lungs, and so on are completely severed only 
by transverse fractures.  Longitudinal fractures tend to be shorter in 
length and shallower in depth, although there were numerous exceptions 
to this generalization.

     In  ischemic animals the kidney was usually grossly fractured  in 
one  or  two locations (Figure 17).  By  contrast,  the  well-perfused 
kidneys of the nonischemic FGP group exhibited multiple fractures,  as 
can  be  seen in Figure 18.  A similar pattern was observed  in  other 
organ  systems  as well; the nonischemic animals  experienced  greater 
fracturing injury than the ischemic animals, presumably as a result of 
the   higher   terminal  glycerol  concentrations  achieved   in   the 
nonischemic group.

     Cannulae  and attached stopcocks where they were externalized  on 
the  animals  were  also frequently  fractured.   In  particular,  the 
polyethylene pressure-monitoring catheters were usually fractured into 
many  small  pieces.   The  extensive  fracture  damage  occurring  in 
cannulae,  stopcocks, and catheters was almost certainly a  result  of 
handling  the animals after cooling to deep subzero  temperatures,  as 
this  kind of fracturing was not observed in these items upon  cooling 
to  liquid nitrogen temperature (even at moderate rates).  It is  also 
possible that repeated transfer of the animals after cooling to liquid 
nitrogen  temperature may have contributed to fracturing  of  tissues, 
although the occurrence of fractures in organs and bulk quantities  of 
water-cryoprotectant  solutions  in the absence of  handling  is  well 
documented in the literature (12, 13).

     There were subtle post-thaw alterations in the appearance of  the 
tissues of all three groups of animals.  There was little if any fluid 
present  in the vasculature and yet the tissues exhibited  oozing  and 
"drip"  (similar to that observed in the muscle of frozen-thawed  meat 
and  seafood)  when cut.  This was most pronounced  in  the  straight-
frozen  animal.  The tissues (especially in the ischemic  group)  also 
had  a somewhat pulpy texture on handling as contrasted with  that  of 
unfrozen,  glycerolized  tissues  (i.e.,  those  handled  during  pre-
freezing  sampling for water content).  This was most in  evidence  by 
the accumulation during the course of dissection of small particles of 
what appeared to be tissue substance with a starchy appearance and  an 
oily  texture on gloves and instruments .  This phenomenon  was  never 
observed  when handling fresh tissue or glycerolized tissue  prior  to 
freezing and thawing.

     There were marked differences in the color of the tissues between 
the three groups of animals as well.  This was most pronounced in  the 
straight-frozen  control  where the color of almost  every  organ  and 
tissue examined had undergone change.  Typically the color of  tissues 
in  the  straight-frozen animal was darker, and white  or  translucent 
tissues such as the brain or mesentery were discolored with hemoglobin 
released from lysed red cells.

     The FGP and FIGP groups did not experience the profound post-thaw 
changes  in tissue color experienced by the straight-frozen  controls, 
although  the  livers and kidneys of the FIGP  animals  appeared  very 
dark, even when contrasted with their pre-perfusion color as  observed 
in those animals laparotomized for tissue water evaluation.


IV. EFFECTS OF CRYOPRESERVATION ON THE HISTOLOGY OF SELECTED TISSUES

     Histology was evaluated in two animals each from the FIG and FIGP 
groups, and in one control animal.  Only brain histology was evaluated 
in the straight-frozen control animal.

Liver

     The  histological appearance of the liver in all three groups  of 
animals  was  one  of  profound injury.  Even in  the  FGP  group  the 
cellular integrity of the liver appeared grossly disrupted.  In  liver 
tissue  prepared using Yajima stain the sinusoids and spaces of  Disse 
were  filled  with  flocculent debris and it was  often  difficult  or 
impossible  to  discern cell membranes.   The  collagenous  supporting 
structures of the bile  canaliculi were in evidence and the nuclei  of 
the hepatocytes appeared to have survived with few alterations evident 
at the light level, although occasional pyknotic nuclei were noted  in 
the FIGP group.  Indeed, the nuclei often appeared to be floating in a 
sea of amorphous material.  Not surprisingly, the density of  staining 
of  the cytoplasmic material was noticeably reduced over that  of  the 
fixative-perfused control.  Few intact capillaries were noted.

     FGP  liver  tissue prepared with PAS stain  exhibited  a  similar 
degree  of disruption.  However, quite remarkably, the borders of  the 
hepatocytes  were defined by a clear margin between  glycogen  granule 
containing  cytoplasm  and non-glycogen containing membrane  or  other 
material  (membrane debris?) which failed to stain with  Yajima  stain 
due to gross disruption or altered chemistry.


Kidney

     PAS  stain  was used to prepare the control, FGP and  FIGP  renal 
tissue for light microscopy.  The histological appearance of FGP renal 
tissue was surprisingly good.  The glomeruli and and tubules  appeared 
grossly  intact  and stain uptake was normal.  However,  a  number  of 
alterations  from  the appearance of the control were  apparent.   The 
capillary tuft of the glomeruli appeared swollen and the normal  space 
between the capillary tuft and Bowman's capsule was absent.  There was 
also marked interstitial edema, and marked cellular edema as evidenced 
by the obliteration of the tubule lumen by cellular edema.  

     By contrast, the renal cortex of the FIGP animals, when  compared 
to  either  the control or the FGP group, showed a  profound  loss  of 
detail, absent intercellular space, and altered staining.  The  tissue 
appeared frankly necrotic, with numerous pyknotic nuclei and  numerous 
large  vacuoles  which peppered the cells.   One  striking  difference 
between FGP and FIGP renal cortex was that the capillaries, which were 
largely  obliterated in the FGP animals, were consistently  spared  in 
the FIGP animals.  Indeed, the only extracellular space in evidence in 
this  preparation was the narrowed lumen of the  capillaries,  grossly 
reduced in size apparently as a consequence of cellular edema.

     Both ischemic and nonischemic sections showed occasional evidence 
of  fracturing, with fractures crossing and severing tubule cells  and 
glomeruli.


Cardiac Muscle

     Yajima  stain  was  used to prepare the  Control,  FGP  and  FIGP 
cardiac  tissue for light microscopy.  The histological appearance  of 
FGP  cardiac muscle was grossly normal with one exception;  there  was 
increased  interstitial  space, probably  indicative  of  interstitial 
edema.    The  banding  pattern  was  normal  and  the   nuclei   were 
unremarkable.   Similarly,  FIGP cardiac  tissue  appeared  relatively 
normal  histologically.   The principal alterations from  control  and 
from  the  FGP  group  were  the  noticeable  presence  of   increased 
interstitial  space  and a more "ragged" or rough  appearance  of  the 
myofibrils where they are silhouetted against interstitial space.

     Most surprising was the general absence of thaw-rigor in the  FGP 
group and only the occasional presence of rigor in the FIGP group.  No 
microscopic evidence of fracturing was noted in either the FGP or  the 
FIGP groups.


Brain

     Bodian stain was used to prepare the control, FGP, and FIGP brain 
tissue  samples  for light microscopy.  Three  striking  changes  were 
apparent  in FGP cerebral cortex histology: 1) marked  dehydration  of 
both  cells  and  cell nuclei, 2) the presence of  tears  or  cuts  at 
intervals  of  10 to 30 microns throughout the tissue  on  a  variable 
basis (some areas were spared while others were heavily lesioned), and 
3) the increased presence (over control) of irregular, empty spaces in 
the neuropil as well as the occasional presence of large pericapillary 
spaces.   These  changes  were  fairly  uniform  throughout  both  the 
molecular layer and the second layer of the cerebral cortex.   Changes 
in  the white matter paralleled those in the cortex with  the  notable 
exception that dehydration appeared to be more pronounced.

     Other  than  the  above  changes,  both  gray  and  white  matter 
histology  appeared  remarkably intact, and  only  careful  inspection 
could  distinguish  it  from control.  The  neuropil  appeared  normal 
(aside  from the aforementioned holes and tears) and many  long  axons 
could be observed traversing the field.  Cell membranes appeared crisp 
and  apart from appearing dehydrated, neuronal  architecture  appeared 
comparable  to  control.  Similarly, staining was comparable  to  that 
observed   in  control  cerebral  cortex.   Cell-to-cell   connections 
appeared largely undisrupted.

     The  histological appearance of FIGP brain differed from that  of 
FGP animals in that ischemic changes such as the presence of  pyknotic 
and  fractured nuclei were much in evidence and cavities and tears  in 
the neuropil appeared somewhat more frequently.

     Both  FGP  and  FIGP  brains  presented  occasional  evidence  of 
microscopic fractures.


V. EFFECTS OF CRYOPRESERVATION ON 
THE ULTRASTRUCTURE OF SELECTED TISSUES

     Ultrastructure was evaluated in two animals from the FIG and FIGP 
groups,  and  in one control animal.  Only  brain  ultrastructure  was 
evaluated in one straight-frozen control animal.


Liver

     Hepatic  ultrastructure  was grossly disrupted, with  the  tissue 
presenting  more as a homogenate than as an organized  tissue.   While 
organelle membranes, particularly rough endoplasmic reticulum, nuclear 
membranes,  and  mitochondrial membranes were frequently  intact,  the 
presence  of intact cell membranes was the exception rather  than  the 
rule.  The  sinusoids, bile canaliculi, and capillaries,  where  these 
structures  were identifiable, were largely filled with  debris.   The 
character of this debris ranged from the relatively amorphous granular 
and  flocculent debris observed in the other organ systems of FGP  and 
FIGP  animals  to  relatively organized  fragments  of  cytosol,  free 
organelles  (naked nuclei and mitochondria being the  most  frequently 
observed),  as well as somewhat structured but unidentifiable  debris.  
In  areas  where discernible hepatocyte membranes  were  visible,  the 
intracellular  contents  appeared washed out and  depleted  of  ground 
substance.  Similarly, the spaces of Disse were hard to  identify  and 
where identifiable were both collapsed and filled with debris.

     In the FIGP animals, intact red cells were frequently in evidence 
as  well  as sinusoids full of what appeared to be  leukocytes  and/or 
leukocyte debris, indicating failed blood washout and probable  failed 
cryoprotective  perfusion as well.  Mitochondria, where  identifiable, 
rarely had much ground substance and presented only faint evidence  of 
cristae.   Nuclei in the livers of both FGP and FIGP animals  appeared 
reasonably  well  preserved  and  the  double  nuclear  membrane   was 
frequently (although not universally) intact.


Kidney

     The ultrastructure of FGP renal tissue was intact to a surprising 
degree.   The  desmosomes, endoplasmic  reticulum,  and  intracellular 
organelles,  with the exception of the mitochondria  appeared  normal.  
Most  mitochondria demonstrated marked enlargement,  decreased  matrix 
density,  disruption of cristae and a few amorphous matrix  densities.  
The nuclei were largely free of margination and clumping of chromatin.  
The glomeruli appeared intact as did tubule and mesangial cells.   The 
architecture of the brush border and urinary space compared  favorably 
to  control  with little debris in evidence.  While there  was  little 
debris in the intercellular spaces, there was extensive debris in  the 
capillary spaces, where it was common to find the capillary completely 
obliterated  and  free  red cells present.   Intact  capillaries  were 
occasionally  observed  in FGP renal tissue.  However,  this  was  the 
exception rather than the rule.

     By  contrast,  the  capillaries in the  FIGP  animals  were  more 
consistently  intact.   The  narrow lumens of  these  relatively  well 
preserved  capillaries  constituted virtually the  only  extracellular 
space  visible.   Also remarkable, given the poor  appearance  of  the 
tissue  at the light level, was the presence of a considerable  amount 
of renal ultrastructure.  The microvilli, glomeruli, and the mesangial 
cells  were all present and reasonably intact.  However,  the  urinary 
space  and  capillary  lumens  were  filled  with  flocculent  debris.  
Ultrastructural  changes in cell organelles were more pronounced  with 
the  nuclei  exhibiting  clumping of  the  chromatin,  the  consistent 
presence of megamitochondria exhibiting loss of integrity of membranes 
and many amorphous matrix densities.


Heart

     Cardiac   ultrastructure  in  both  FGP  and  FIGP  animals   was 
reasonably  well  preserved.  The sarcoplasmic  reticulum,  transverse 
tubules,  intercalated  discs,  and banding  of  the  myofibrils  were 
comparable to that of control.  A notable abnormality in both the  FGP 
and FIGP myocardium was the presence of severe interstitial edema,  as 
evidenced by greatly increased interstitial spaces littered with  both 
granular  and  flocculent  debris.   There did  not  appear  to  be  a 
significant  difference  in the quantity, character,  or  location  of 
debris  between  the FGP and FIGP animals.  No significant  amount  of 
fibrolysis was noted in either the FGP or the FIGP groups.

     Also notable was the presence of megamitochondria, with decreased 
matrix  density  and disruption of cristae.   Occasional  mitochondria 
with  normal density were observed in FGP animals.  However, this  was 
virtually never the case in the FIGP animals.  Myocardial  capillaries 
were  grossly  intact,  with  only the  infrequent  presence  of  what 
appeared  to be very small areas of focal injury involving  separation 
of the endothelial cell membrane from basement membrane.  Small  areas 
of  rigor evidenced by the presence of severe contraction  bands  were 
sometimes  present  in the FIGP group but were not noted  in  the  FGP 
group.  


FGP Brain

     At  the  outset it should be noted that evaluation  of  the  fine 
ultrastructure of FGP cerebral cortex is complicated by the degree  of 
apparent  dehydration  of intracellular  structures  present.   Ground 
substance  was  markedly increased over control and most,  though  not 
all,  axons  appeared shrunken, electron-dense, and  surrounded  by  a 
periaxonal space.  Intraorganelle structures were frequently difficult 
to  identify  as  a  result  of  dehydration,  with  many   structures 
presenting an electron dense but amorphous interior.  

     These  effects notwithstanding, the overall architecture  of  the 
tissue  could be discerned. Intact neuronal, glial, and vascular  cell 
membranes  were  uniformly present.  Such interstitial  space  as  was 
present  consisted  of  periaxonal shrinkage  spaces  and  irregularly 
shaped  cavities,  apparently artifacts of ice  formation,  of  widely 
varying  size, often containing small quantities of organized  debris, 
which  peppered  the  tissues at intervals of 5 to  10  microns.   The 
largest  of these cavities appeared to be 20 to 30 microns across  and 
presented the appearance of tears or rips, with the two opposing sides 
of the gap presenting a rough match.  Smaller cavities 1-3 microns  in 
diameter  were  more frequently present than  these  relatively  large 
tears.  

     The  capillaries  appeared  reasonably intact,  with  the  lumens 
containing  no or modest amounts of relatively well organized  debris.  
However,  the  capillaries  were frequently  surrounded  by  cavities.  
These  cavities varied in size from a few microns to 10 to 15  microns 
in diameter with the cavity separating the capillary from  surrounding 
brain  cells usually circumscribing from one-third to one-half of  the 
capillary perimeter.

     Axons usually appeared intact, but shrunken.  However, it  should 
be  noted  that  some spaces characteristic of  axons  and  containing 
myelin debris (but no axon) were also present in most sections of  FGP 
brain  examined.  Myelinated tracts were often difficult  to  evaluate 
due  to the degree of dehydration.  However, unraveled  and  disrupted 
myelin  was  commonplace, often surrounding  an  intact-looking  axon.  
Synapses  were  present  in numbers comparable to  that  seen  in  the 
control and were especially well preserved, presenting grossly  normal 
architecture, including clear pre- and post-synaptic densities and the 
presence of synaptic vesicles.

     The  nuclei  were  highly condensed (presumably  an  artifact  of 
dehydration)  and  sometimes contained unusual gaps  or  spaces  which 
might  have occurred as a result of dehydration from  glycerolization, 
the formation of intranuclear ice, or ultramicroscopic fractures as  a 
result  of  differential  contraction during cooling  below  Tg.   The 
mitochondria appeared dense and amorphous.


FIGP Brain

     The  FIGP  brains  presented  an  "exploded"  appearance  at  the 
ultrastructural level.  Virtually every structure appeared swollen and 
there  were  large amounts of interstitial space.  A uniform  but  not 
universal  alteration  was  massive swelling  and  unraveling  of  the 
myelin.  Typically there was about a 5-fold increase in the  thickness 
of  the  myelin  sheath, with a  corresponding  decrease  in  electron 
density.   Often the individual sheets or "turns" of myelin  could  be 
easily  discerned,  with separating spaces between  each  layer.   The 
presence  or absence of intact axons within this disrupted myelin  was 
highly  variable; in some regions the axons appeared  well  preserved, 
with  neurofibrils and microtubules clearly visible, while  in  others 
apparently nothing but debris remained.  

     Mitochondria were uniformly swollen and presented varying degrees 
of  internal structure ranging from easily identifiable cristae  to  a 
fine-grained  amorphous appearance.  In contrast to FGP  brains  there 
was  virtually  no  dehydration in evidence in  the  FIGP  brains  and 
intracellular  structures and small processes such as neurites,  where 
intact,  were easily identified.  The nuclei appeared more like  those 
present in the control and did not show the peculiar gaps or  cavities 
present in the FGP group.

     Small  cavities and large gaps peppered the tissue as in the  FGP 
cerebral  cortex.  These cavities contained considerably  more  debris 
than  those in the FGP brains and the debris were less structured  and 
frequently  appeared  flocculent  and/or  granular  in  nature.   Cell 
membranes  were frequently disrupted and masses of free  cytosol  were 
common.    Synapses,  synaptic  vesicles  and  what  appeared  to   be 
occasional  synaptic debris were noted with a frequency comparable  to 
that of the control.  
    

VI. SUMMARY AND DISCUSSION

Glycerolization

     Cryoprotective  perfusion  of  non-ischemically  injured  animals 
resulted  in profound dehydration.  This dehydration was  particularly 
pronounced  (in  terms  of  visual appearance)  in  the  brain,  eyes, 
skeletal  muscle,  and skin.  While it can be argued that  removal  of 
interstitial  and  intracellular  water may be  useful  in  minimizing 
mechanical  injury during subsequent freezing since less  water  means 
less ice, it can also be argued that glycerol is failing to adequately 
penetrate   cells   and   thus  is   providing   less   than   optimum 
cryoprotection.   Certainly  the profound  dehydration  documented  in 
these animals (and similarly noted in human patients) is indicative of 
a  failure of cellular equilibration of glycerol, particularly in  the 
brain  and  skeletal  muscle,  and in and  of  itself  is  probably  a 
significant source of osmotic injury.  

     In  an  unpublished pilot study we tried to determine  if  better 
glycerol   equilibration   could  be  facilitated  by   carrying   out 
cryoprotective   perfusion  at  18*C.   Both  the  gross  effects   of 
dehydration  and the measured water losses from tissues (including  in 
the  brain,  which was determined to be 28% in the  single  experiment 
conducted) indicated that glycerolizing at higher temperatures is  not 
the  solution to this problem.  Clinically it has been known for  many 
years that infusion of significant amounts of glycerol at normal  body 
temperatures,  as  in the case of inadvertent transfusion  of  frozen-
thawed  red  cells without deglycerolization, results in  rapid  death 
from cerebral dehydration (14).  Indeed, glycerol has been used as  an 
osmotic agent to control cerebral edema in the traumatized brain (15).  
Thus,  glycerol would seem to be a poor choice of  cryoprotectant,  at 
least in terms of its cellular permeability, for the brain.   Clearly, 
a  cryoprotective  agent(s) capable of better equilibration  with  the 
intracellular space of the brain is needed.

     In  the ischemic animals, the gross effects of  dehydration  were 
less  obvious or were not seen due to the occurrence  of  interstitial 
edema.  However, cellular dehydration might not have occurred in these 
animals,  perhaps as a result of increased cell membrane  permeability 
due to ischemic changes such as phospolipase (16) or free radical (17) 
mediated  degradation of cellular and organelle membranes.   Certainly 
the  intracellular  organelles  and  axons did  not  have  the  dense, 
collapsed,   dehydrated   appearance  of  these  structures   in   the 
nonischemic animals.

     This  noticeable  change in cellular glycerol  permeability,  the 
loss of capillary integrity as evidenced by the development of serious 
interstitial  edema in the brain and virtually all other  body  organs 
with  the exception of the liver (which apparently failed  to  perfuse 
significantly),  the patchy nature of perfusion due to  clotting,  and 
the failure to reach target glycerol concentration as a result of  all 
of  these effects is indicative of the profound deleterious impact  of 
ischemia  and  of  the  importance of  minimizing  ischemic  time  and 
inhibiting  mechanisms  of  ischemic  pathology  in  human  suspension 
patients  if  adequate  distribution  and  terminal  concentration  of 
cryoprotectant is to be achieved.


Histology 

     The  histological  preservation achieved in  brain,  kidney,  and 
heart  in both ischemic (excluding ischemia-associated alterations  to 
nuclei) and non-ischemic animals was surprisingly good considering the 
magnitude  of  the insult.  In the case of the FGP  brains  structural 
preservation  appeared  excellent and  almost  indistinguishable  from 
control, with the exceptions of the presence of an increased number of 
empty  cavities  and  more light-lucent areas,  and  the  presence  of 
obvious tears at 10 to 20 micron intervals in the neuropil.

     Similarly, the histological preservation of the renal cortex  was 
surprisingly good in both the FGP and the FIGP animals.  The glomeruli 
were  generally intact and this is surprising considering the body  of 
data  from renal cryopreservation studies documenting  destruction  of 
the glomerulus due to ice formation (18, 19).  Perhaps the reason this 
did  not occur in our animals was the very slow rate at which  cooling 
was carried out (4*C/hour) as contrasted with the comparatively  rapid 
rate at which kidneys are cooled during cryopreservation  experiments.  
Such comparatively slow cooling rates may have allowed time for  water 
to migrate out of the glomerulus to other sites during freezing  (20), 
and/or the distortive and disruptive effects of ice formation may have 
been  minimized  by the plasticity of these structures at  the  higher 
temperatures at which most ice formation and growth occurs.

     Histological preservation in cardiac tissue in both FGP and  FIGP 
animals  was  also  remarkably  good and it  was  often  difficult  to 
distinguish   ischemic  from  non-ischemic  tissue   without   careful 
observation.


Ultrastructure

     The  ultrastructural preservation of the brain  was  unexpectedly 
poor  in  all  three groups of  animals:  ischemic,  non-ischemic  and 
straight-frozen.    Not  unexpectedly,  the   straight-frozen   animal 
presented the worst ultrastructural appearance.  The ischemic  animals 
also suffered extensive ultrastructural disruption.  This was somewhat 
unexpected given the relatively good appearance of brain tissue at the 
light  level; in particular it appeared that membranes were crisp  and 
well preserved that cellular ground substance was of reasonably normal 
density,  and  that  the  overall  ground  substance  density  of  the 
neuropil,  as well as the preservation of long individual axon  fibers 
and cell-to-cell connections, were largely intact.  Unfortunately, the 
degree of ultrastructural injury observed was in sharp contrast to the 
apparently  good  histological  preservation.  The  profound  loss  of 
ground  substance,  gross and widespread loss of  membrane  integrity, 
presence  of extensive debris, and the widespread destruction  of  the 
myelin   all  underscore,  yet  again,  the  critical  importance   of 
protection of suspension patients from cerebral ischemia.

     While  the  degree  of  ultrastructural  disruption  was  not  as 
profound in the brains of the FGP animals, it was far from acceptable.  
The  presence  of frequent ice holes, tears in the neuropil,  and  the 
cellular  dehydration  and fracturing observed are all  indicative  of 
unacceptably  poor  preservation  and point to  the  urgent  need  for 
additional research to ameliorate or eliminate these problems.

     Given the severity of the ultrastructural disruption observed  in 
the  brains  of all three groups of animals, it is certainly  open  to 
question  whether  or not sufficient structure is being  preserved  to 
allow  for resuscitation of cryonic suspension patients  treated  with 
similar  techniques  (and presumably injured  comparably)  with  their 
memories and personalities intact.


Freezing Versus Thawing

     The  especially  poor  perfusion of the  liver  in  the  ischemic 
animals   was  unexpected.   Additionally,  the  poor  ultrastructural 
preservation   observed  in  the  nonischemic  animals  is   puzzling, 
especially  in  light of the apparent good perfusion  and  amounts  of 
water  loss (which were comparable to those experienced by  the  heart 
and kidney during glycerolization).

     The relatively good ultrastructure of the kidney and heart in the 
FGP  and to a lesser extent in the FIGP group stand in sharp  contrast 
to  widespread disruption seen in the brain.  The reason(s)  for  this 
are  not clear.  However, a possible explanation might be the  failure 
of   glycerol   to  penetrate  brain  cells   and   provide   adequate 
cryoprotection.  It should be noted that the amount of water lost from 
the  brain  during  glycerolization,  while  not  directly   measured, 
appeared  by  gross  examination  to be  roughly  comparable  to  that 
observed  in the heart and kidney, both of which were, by  comparison, 
much better preserved. 

     Some caveats regarding these results should be considered.  First 
of  all, examination of the tissues was conducted  following  thawing.  
This  introduces the possibility of significant "stirring" of  damaged 
structure  not  only during thawing, but also  during  sectioning  and 
fixation,  since re-perfusion with fixative was not possible owing  to 
disruption  of  the vasculature by fractures.  This is  potentially  a 
particularly  troubling  "artifact"  because a major  concern  is  the 
presence  of debris many microns from the likely source of origin  (as 
observed  in  the  liver and brain).  When and  how  this  debris  was 
translocated from its point of origin, as well as its character (i.e., 
how  unique  are the fragments of debris; can their precise  point  of 
origin  and orientation be determined?) is of critical  importance  in 
determining whether or not repair can be undertaken.  If the extensive 
ultrastructural and molecular-level stirring observed in these animals 
occurred as a result of diffusion/stirring which took place during, or 
even  after  thawing and/or during sectioning and fixation,  then  the 
situation  is  considerably more hopeful than if the  damage  occurred 
during the freezing process.

     It  will  not  be  easy to determine how  much  of  the  observed 
disruption  is  a  result of freezing, and how much  is  a  result  of 
thawing  and/or post-thaw diffusion-driven processes.  Depending  upon 
the degree to which the microvasculature is intact following  freezing 
and thawing it should be possible to eliminate pre-fixation sectioning 
and  handling of the tissue as a source of artifacts by the  expedient 
of  not cooling to below the glass transition temperature of  the  the 
water-cryoprotectant mixture, thus effectively avoiding fracturing and 
allowing  for fixative reperfusion upon thawing.  However,  evaluating 
the  degree  to  which freezing, as opposed to  freezing  followed  by 
thawing,  results in the disruption of, and perhaps more  importantly, 
the  translocation  of cell structures would not be resolved  by  this 
means.

     Finally, it is especially important to point out that this was  a 
pilot  study.   During  the  evaluation  of  the  light  and  electron 
microscopy  it  became apparent that additional  control  groups  were 
needed  to  resolve many important questions left unanswered  by  this 
work.  In particular, post glycerolization/pre-freezing ultrastructure 
and  histology should have been evaluated to separate the  effects  of 
glycerolization  from  the  effects  of  subsequent  cryopreservation.  
Similarly, a group of post-thaw cryopreserved tissues should have been 
deglycerolized  prior  to fixation in order to  allow  for  evaluation 
without the confounding effects of glycerol-induced dehydration.

     Freeze substitution studies at both the light and EM levels would 
also be useful in helping to relate the lesions observed (gaps, tears, 
cavities  and so on) to mechanical injury resulting from the  presence 
of ice.

Technical Issues

     Some of our most serious caveats are technical in nature.   Brain 
slicing with a Stadie-Riggs microtome could have obliterated structure 
in  and  of  itself,  particularly  if  the  frozen-thawed  brain   is 
structurally  weaker  than a control brain (as is to  be  expected)  .  
However, this criticism does not apply to the the electron  microscopy 
since  tissue  examined by EM was from the center of the  slice,  away 
from the cut surface. 

Summary

     Evaluation  of  a  cryopreservation  protocol  which  is  broadly 
similar  to  that  being  used  in  human  cryonic  suspensions  today 
discloses  poor ultrastructural preservation of the brain, the  target 
organ   of   the  preservation  process.    The   comparatively   good 
ultrastructural  preservation  of the heart and kidney  indicate  that 
better results are possible and strongly suggest that the preservation 
protocol currently in use is not optimal for the brain and results  in 
unacceptable levels of ultrastructural disruption.  There is an urgent 
need for additional research to address this problem.

     The   impact   of  prolonged  ischemia   on   tissue   histology, 
ultrastructure, and perfusion was profound and underscores the need to 
protect suspension patients from ischemia.


TABLE I.

Composition Of Modified Karnovsky's Solution

Component                         g/l

Paraformaldehyde                 40
Glutaraldehyde                   20
Sodium Chloride                   0.2
Sodium Phosphate                  1.42
Calcium Chloride                  2.0 mM

pH adjusted to 7.4 with sodium hydroxide.
_________________________________________

TABLE II

Perfusate Composition

Component                           mM

Potassium Chloride                  2.8
Dibasic Potassium Phosphate         5.9
Sodium Bicarbonate                 10.0
Sodium Glycerophosphate            27.0
Magnesium Chloride                  4.3
Dextrose                           11.0
Mannitol                          118.0

Hydroxyethyl Starch                50 g/l


TABLE III.

Total Water-Loss Associated With 
Glycerolization Of The Cat
____________________________________________________
Animal    Pre-Perfusion    Post-Perfusion     Kg./     % Lost As      
  #          Weight Kg.        Weight        Water     Dehydration

FGP-1          4.1              3.6           2.46        18            

FGP-2          3.9              3.1           2.34        34            

FGP-3          4.5              3.9           2.70        22            

FGP-4          6.0              5.0           3.60        28            

FIGP-1         3.4              3.0           2.04        18            

FIGP-2         3.4              3.2           2.04         9

FIGP-3         4.32             3.57          2.59        29


References

In Preparation