X-Message-Number: 2907 Date: 17 Jul 94 23:38:26 EDT From: Mike Darwin <> Subject: SCI.CRYONICS high glycerol concentrations Regarding the use of high concentrations of cryoprotectant (in this case glycerol) Bob states the following: <<That cracking occurs more readily in the presence of concentrated glycerol seems to imply--other things equal--that high concentrations are undesirable. The push by Mike (and Alcor when Mike was there) toward very high concentrations seems to be related (my impression) to the push toward vitrification rather than freezing. But since vitrification is still unperfected, it may be that imperfect freezing is better than imperfect vitrification. We'll see.>> Alas, other things are NOT EQUAL. The reason(s) why we went to progressively higher concentrations of glycerol are, regretably, not nearly so theoretical (i.e., wishing to approach or achieve vitrification) as Bob speculates. The story goes something like this: 1) The choice of 3-4 M glycerol for cryoprotection was based on an extrapolation from nature. In the 1950s Audrey Smith observed that hamsters could tolerate about 60% of their brain water being converted into ice and still recover apparently neurologically intact (although neither she nor anyone else had done studies to verify that learned behavior -- memory -- was intact in animals so treated). Conversion of 60% of the water in a mammal's brain to ice seemed to be compatible with neurlogical recovery and this volume % of conversion of water to ice in the brain became known as "Smith's Criterion." It is important to realize that Audrey Smith cooled her hamsters to a core temperature of about -0.5C and brain core temperature of maybe about -0.75C to -1.0C -- at those temperatures tissue will have about 60% of its water converted to ice at the one hour mark (Smith's hamsters did not typically survive more than one hour of freezing, longer periods were lethal). Of course, we are going to be cooling cryopreservation patients to a far lower temperature, in fact cooling them to -196C. However, for practical purposes in terms of the amount of ice formed, the changes are all completed by far high temperatures -- say around -50C to -60C. So, the question was, looking at a phase diagram for glycerol-water solutions, how much glycerol do you need to satisfy Smith's criterion of converting no more than 60% of the brain's volume into ice? The answer, about 4M glycerol. We started perfusing people with 4M glycerol. This was documented in a paper Leaf, Darwin (Federowicz) and Hixon entitled Case report: Two consecutive suspensions, a comparative study in experimental human suspended animation (Cryonics (6(11), 13 (Nov 1985)). 2) Starting in the early 1980's we decided to see just how well we were doing using both ischemic and nonischemic animals in a "cryonic suspension" model: employing glycerol perfusion to 3-4M and freezing to -196C and rewarming and subsequent evaluation by light and electron microscopy. What we found was not good. There was massive injury to brain -- so much so that the experts I had look at it called it a "tissue homogenate." While it was not quite that bad, it was pretty bad. The liver in these animals (cats) looked even worse (it truly was a tissue homogenate!). However, by contrast the heart and kidney were surprizingly well preserved -- still severely damaged, but at least the overall architecture of the tissue was intact and much of the damaged structure seemed "inferable.". This seemed paradoxical. Meanwhile, Greg Fahy's whole brain glycerolization and freezing experiments pointed to less injury with high concentrations of agent. He recommended that we go to 5M glycerol. 3) Further studies were undertaken by Greg Fahy a few years later. Greg used a perfusion model employing rabbits perfused to 3.67M glycerol but as opposed to thawing the tissue, fixing it and evaluating it, he cut it into blocks at -140C (using a band saw), fractured out brain tissue away from the cuts, and freeze-substituted and fixed it at -79C. This technique allows one to look at how and where the ice has actually formed to damage the tissue. The results of these studies were shocking. I hate to use a word like that because it is so loaded and unscientific, but I am at a loss to find a more descriptive one. I believe I can justify the use of that word by using lots of others to describe the results of these studies. There was massive and large ice crystal formation in the brain. A lesion which was very frequent in my cat EMs (after thawing) was the presence of gaping pericapillary holes and frequent 10-30 micron tears in the neuropil at 30-50 micron intervals. These lesions were also seen in the frozen state: they were caused by clearly visible masses of ice. But of greater concern still was the overall large-scale compression and distorition of the tissue in almost every plane on both an ultrastructural and a histological level. Furthermore, long processes (axons, dendrites) were cut with great frequency in every direction on the histological level (it was less possible to tell this at the EM level because the field of view is so much smaller). That's how we first arrived at 4M glycerol and how we went to 5M. We knew nothing about cracking at that time. True, we had observed it in solutions of glycerol-water which could be vitrified (i.e., 72% glycerol) but it did not occurr to us it was happening in biological systems subjected to freezing with subvitrifiable concentrations of agent present. On the basis of the freeze-substitution studies we decided to experiment with higher concentrations of glycerol: up to 6M. We found this concentration to be perfusable, and we found it to markedly reduce the ice injury. We knew about fracturing by this time. ereg then began to undertake a complex and reasonably exhaustive series of experiments with rabbit brain slices evaluating a wide variety of cryoprotectants and mixtures of cryoprotectants. So far, as of this writing, glycerol still appears to be best, although at my urging he has (a few days ago) completed an experiment using vitrification solution. High concentrations of glycerol (approaching 7M) were far more protective histologically and ultrasructurally) than lower concentrations. Thus, we had a choice: do we want to accpt massive ultrastructural and histological injury and forgoe macroscopic cracking (even though we knew that microscopic fracturing would *still* occur with lower concentrations of agent) or did we want to further suppress the ice injury and accept (temporarily, at least until intermediate temperature storage could be developed) gross cracking injury? We chose the latter. And we did this only after careful consultation with a wide variety of knowledgeable people such as Greg Fahy, Ralph Merkle, and Eric Drexler. Did we make the right choice? Well, as Bob says, "we'll see." Part of my problem with Bob's postings is that they simply do not acknowledge that all this work has been done and that this informations EXISTS. Reports of this data have been published and presented at cryonics conferences and symposia for nearly a decade. In fact, my first papers on the ultrastructural and histological preservation of cat brains were made at the Lake Tahoe Life Extension Festivals in the mid-1980's. Videotapes of these presentations were available from the Festival (Fred and Linda Chamberlain) and the videos were more than adequate to show the lesions displayed on the 35 mm slides being projected and the extensive discussion of materials and methods which accompanied them. I know that Alcor still has copies of these tapes and I would not be surprized if both Alcor and the Chamberlains would still be willing to make them available. If they are, I would very much like a copy -- I don't have one myself! The point is, no one from CI apparently viewed these tapes, attended the presentations, or even asked for the details. Ditto for my Cryonet posted copy of the paper describing this work! In fact, no one but Thomas Donaldson and Mike Perry have ever even asked to *look* at the EMs of the brain and other organs from this study. This total lack of interest left me more than a little disheartened. In fact, I concluded that most people just don't care. They are quite content to let the future sort out all the problems. Now, I hardly mean to represent my cat data as the be-all-end-all. In fact, it is a woefully inadequate study with many caveats. I didn't realize how inadequate till I started writing it up a number of years ago. But it still deserves to be looked at, and the fact is that some of the most troubling lesions we observed were subsequently observed by another, independant investigator. And incidentally, I also have a collection of EM's from straight frozen brains and brains frozen with low concentrations of glycerol. If you think that's the better approach, forget it! A tissue homogenate *is* the operative description in these cases (at least after thawing -- an important caveat). One major difference in the CI technique from what is used in humans (I presume) by CI and from is used in humans elsewhere is that as I understand it CI *uniformly* cut a large window in the skull. This may have eliminated or reduced the "container effect" which we have all observed in the past. For instance it is possible to cool *isolated* brains loaded with high concentrations of cryoprotectannt to -196C without cracking if you peel them away from the container they are in before cooling below the glass transition point. The work being done by the Russians should definitely look at some heads where the brain case has not been opened in this fashion. In humans that I am preparing for cryopreservation, if there is cerebral shrinkage, I am now making it a point to suction off all the fluid from the cranial vault so that brain is mostly out of contact with its container in the hopes that will reduce, if not eliminate cracking. Also, we can hope against hope that very slow cooling rates *are* the protective thing in the sheep heads and this will be applicable to humans. Finally, Bob notes: <<MIke says Terri Cannon was cooled from dry ice to liquid nitrogen temperature in about 12 days, whereas we usually take only 7 days. However, he also says she was cooled to dry ice temperature in only two days, whereas we take 7 days for this phase also.>> This is true, and there is good reason for it. For one thing partients loaded with multimolar concentrations of glycerol will freeze at subzero temperatures. It is also important to cool them to their freezing point and reduce their temperature reasonably rapidly to inhibit biochemical/autolytic changes going on at higer temperatures. As I understand it, Bob places his patients after perfusion in a sleeping bag and then gas cools them by slowly lowering them in LN2. My suspicion is that these patients are spending many, many hours (if not days) above, at, or near their freezing temperatures. The reason for this assumption is that most of heat that has to be removed is the latent heat of fusion when the water freezes. An insulated patient in an air cooled environment will present a big load of calories to dissipate leaving the patient's core temperature hanging at the freezing point for a long time. This is why we (BPI and Alcor) use a liquid bath because it gets us over this "hump" and moves the heat rapidly (i.e., 3-4C /hr) at relatively high subzero temperatures. Temperatures at which biochemical activity is still very active. We ran into this problem many years ago with the Berkowitz cryopreservation; he was placed in a container thinly wrapped in fiberglass insulation and his cooling rate was *very* slow. Furthermore, while I could be wrong, I do not think there is any evidence that the rate of cooling to temperatures considerably above Tg has any effect on subsequent fracturing. Certainly both our experienmts with bulk solutions and Greg Fahy's work do not bear this out. Reasonably rapid cooling to at -60C would seem prudent. Whole body patients of course do take longer to reach this temperature -- about 3 days in a liquid bath. I would be very interested in seeing specific data from Bob's patients. I have the following questions: 1) How are CI patients prepared for cryopreservation? How is the perfusate prepared/stored, how is perfusion carried out (temperatures, pressures, flows, etc). Ditto for transport procedures. 2) Can you post or send to interested parties copies of cooling curves for CI patient(s) which show at least surface versus core temperatures? 3) Are such data available for the sheep head work? The availability of this specific data would be very helpful in comparing notes and determining what is important. Finally, what we have here as much as anything is a lack of communication. The band width has been very narrow or even nonexistent. I am not concerned about making an issue of why this has been so. I'll be happy to accept any reasonable share of the responsibility that is mine. Much more to the point is *fixing* the problem. There is going to be a conference in November. I think this would a very good opprtunity for everyone to get together and discuss these issues. And if the September conference is too soon or inappropriate, perhaps another meeting, exclusively focused on ischemic and cryopreservation injury could be set up -- perhaps somewhere more centrally located in the United States (Detroit, Indianapolis, St Louis?). I think we could all benefit by sharing information and by talking in detail about where we go from here. We each have unique strengths in our capabilities. It would be very nice to exploit those strengths -- including those available in Russia, to our mutual advantage. What about it? Mike Darwin Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=2907