X-Message-Number: 16152 From: Date: Sun, 29 Apr 2001 00:19:35 EDT Subject: (no subject) Kryos News #2 New Facility Update Construction and outfitting of the new Kryos facility is now well underway. We hope to be through with the most tedious work (plumbing, casework, wiring and the like) within about 3 weeks. After that we will begin moving in equipment and setting up for our preliminary "validation runs" to ensure that we can deliver the currently medically reversible parts of the procedure with high quality. To many readers the notion that any part of human cryopreservation procedures are reversible will come as a surprise. However, recovery of healthy animals from a period of cardiac arrest followed by resuscitation and cardiopulmonary bypass has been routine for several years. Furthermore, as long as 9 years ago Biopreservation, Inc. demonstrated consistent long term survival of dogs following 5 hours of bloodless perfusion at a temperature of few degrees above the freezing point of water. Before we receive our first human patient, we plan to simulate all the procedures of cryotransport and perfusion using an animal model. If our procedures are as successful as we hope, we will resuscitate our animal subject with no residual damage. We have been repeatedly asked if Kryos services or the Kryos facility will be available to other cryonics organizations on a contract basis? The answer is that once we are operational we will open the facility on a contract basis for use by any qualified cryonics society that may wish to use it. Some organizations with no facilities in the state of California may find this desirable for regulatory reasons, among others. By way of example, just recently a cryonics organization was faced with a situation where a patient experienced legal death after the Department of Health Services Vital Statistics Office had closed. Legally it is all but impossible to move a "body" out of California without a removal or burial transit permit. Fortunately, this patient was a neuropatient and the solution to the problem was cephalic isolation in a local mortuary and transport of the patient out of state as a cephalon as opposed to a whole body. Obviously, this would present a problem for whole body patients. The more regional facilities which exist that are capable of administering high quality treatment including proceeding to vitrification (where appropriate) the better the level of care will be for cryopatients everywhere. Questions About Kryos We've received a lot of questions about Kryos and have done our best to answer them individually. However, this is not a very efficient way to go about it, and the primary reason for Kryos News is to serve exactly that function. With this in mind we thought we'd tackle the most frequently asked questions (so far). Will Kryos have access to state-of-the art vitrification technology? We are confident that we will be offering this technology, since we have satisfied two of three conditions imposed by 21st Century Medicine, and expect to have no difficulty meeting the third. What kind of services will Kryos offer? We plan on being a full service cryopreservation organization. By this we don't mean that we will offer services other than those focused on human and companion animal cryopreservation. We believe that the job of delivering, let alone perfecting clinical cryopreservation is so great that the only business of Kryos is the cryonics business. What specific services will Kryos offer? We plan to offer both whole body and neuro cryopreservation. Our first and most urgent focus will be on validating the extent to which current neurovitrification techniques are effective in the clinical setting. While several human neuropatients have been treated with a vitrification protocol it is difficult to be certain to what extent ice formation was suppressed. This is a more difficult problem than it might at first seem to be. The typical way that failure to vitrify is established is by carefully recording the cooling curve of the specimen or patient being vitrified. If vitrification fails ice will form and ice formation results in the release of heat which can be seen as a plateau or "bump" on the otherwise smooth cooling curve. This is a very useful indicator of a major failure of vitrification. Unfortunately, in the real world cryoprotective distribution may be inhomogenous and freezing of small areas of tissue may occur over a range of temperatures. Also, some tissues may experience partial freezing, again occurring slowly during cooling and not generating enough heat to be detected by temperature probes placed in very well perfused tissues. In the laboratory the amount of ice formed can be measured by a technique called direct calorimetery where the total amount of heat removed from the specimen can be directly measured. Unfortunately, this technique is not very practical for clinical application. Thus, other techniques will have to be used. Kryos has developed several approaches to validating that vitrification is occurring uniformly in the patient as well as identifying areas where freezing is occurring. We are particularly concerned that ice formation may still be occurring in areas of the brain such as the white matter (which is very poorly perfused compared to the gray matter and also consists of relatively water-impermeant myleinated axons) and in the brain tissue adjacent to the fluid-filled cerebral ventricles. We are also concerned about the retina of the eye due to the presence of large amounts of water in the non-perfused gel of the vitreous humor. With rapid advances in stem technology and in engineered tissues it may be possible to replace any tissue which is too badly damaged with the exception of the brain. Our focus will thus be first and foremost on the brain the rest of the nervous system. Once we have validated neurovitrification we will endeavor to try to extend vitrification to as many organs in the whole body as possible. We are relatively unconcerned about modest amounts of ice formation in some tissues, but we want to overcome large-scale freezing in vital organs and especially avoid failure of vitrification in areas that are vascular "dead ends" such as the chambers of the heart and the pulmonary circulation. We plan on offering both neuro and whole body storage. Initially we will be able to offer low fracture or fracture free storage only to neuropatients. A major obstacle to be overcome, aside from the need for stable and safer higher storage temperatures, is to avoid fracturing as a result of the very high temperature difference between the surface and core of the patient during external cooling. With current vitrification techniques it is necessary to cool the patient very rapidly to avoid ice nucleation (which necessitates very high rates of rewarming if freezing is to be avoided during revival) or worse, actual freezing. We believe we have approaches which will prevent fracture-associated injury during cooling. These will need to be validated in a clinically relevant model. The next objective will to extend this technology to whole body patients. We understand that a major effort to achieve whole body vitrification will be undertaken by a non-cryonics related organization sometime in the next year. This is good news for Kryos since it will allow us to focus our efforts on service delivery, marketing, and research to further improve brain viability. We will also be offering Standby (both local and remote) and vastly improved transport technology. Current transport techniques fail to prevent an enormous amount of both gross and molecular-level damage which occurs as a result of ischemia (interrupted blood flow) following legal death. This damage is not only of direct concern, but has possible indirect consequences for cryopatients. Ischemic injury seriously interferes with uniform and adequate distribution of cryoprotectant resulting in either much addition damage during perfusion, and still more damage during freezing or vitrification. Indeed, such ischemic changes may prevent many patients from being vitrified. In future issue of Kryos News we will be explaining the details of these ischemic changes and the approaches we will be using to prevent or reverse them. Some of this information is cutting edge science which has not previously been disclosed. We find it exciting and we think you will too. Kryos personnel have validated the use of these ischemia inhibiting techniques in dogs and other animals and have applied some of the technology to one human cryopatient with much improved results (see the Cryopreservation Case Report of James Gallagher). Kryos plans to make this technology available to other cryonics organizations through licensing where interest exists. Finally, as previously mentioned, Kryos will offer companion animal cryopreservation. How much will Kryos' services cost? We are still in the process of determining our costs. A significant cost will be access to the highest quality of vitrification technology. While we have no firm numbers at this time we anticipate that there will be significant increase in cost over our pre-launch projections. Until this issue is clarified we will not be able to give reliable cost figures for the whole procedure from Standby to Storage. Will Standby be part of Kryos' human cryopreservation package? Yes. We firmly believe that offering cryopreservation without Standby and prompt intervention to prevent ischemic injury is like selling a car without the engine. Standby will be an integral part of Kryos' program. To this end a great of effort will be focused on refining Standby launch criteria and in monitoring the patient's condition during the last days and hours of terminal illness. Streamlining and automating Transport will a key area of Kryos' focus with the effort being on reducing the most expensive element of both Standby and Transport: personnel. Is Kryos a for profit company? Yes, Kryos is for profit corporation incorporated in the state of Delaware. Kryos believes that a profitable human cryopreservation business is possible and that the focus of any company offering cryopreservation services should be just that. We believe that the best way to achieve high quality service is to use the profit motive tempered with the years of experience Kryos' personnel have in delivering cryonic care. When will non-US services be available? This will be an extended process. To a great extent how fast things progress will depend upon the efforts exerted by our potential customers outside the US. Our first focus will on Canada because it closer and easier to deal with logistically. We had hoped to be able to deliver services to the UK at almost the same rate, however we understand that the Alcor UK facility is being sold and there will be a protracted period of time where no physical plant exists which is suitable for delivery of vitrification. Other problems also appear to exist in the UK which may delay deployment of services there for some time to come. We find this situation bordering on the tragic. Unfortunately, there appears to be little that can be done to avert the dismantling of the UK facility which will preclude early deployment of vitrification and advanced Transport technology for the foreseeable future. Do we need help? Many people have asked if we can use assistance of various kinds? The answer is "Yes!" We aren't proud and we aren't prejudiced. We don't care what cryonics affiliation you have. We don't see Kryos as a negative to any existing cryonics organization. In fact, quite the reverse. The approach we are taking will be unique; otherwise we wouldn't bother with all this effort! We need help in many areas running the gamut from high level technical skills to a good used coffee maker. If you can help, let us hear from you. In the next issue of Kryos news we'll run a short list of nontechnical things we need. Starting a new cryonics business is a lot like setting up a new household. You may most of the furniture and appliances, but you still have to spend a fortune on garden hoses, household cleaners, and other "little things" that we take for granted because we've accumulated them slowly over time. Those little things add up to a fair amount of money. We hope the above answers most of the questions many of you have. If you have questions we have not addressed, please ask us and we will do our best to answer them in future issues of Kryos News. Just write to E. Shaun Russell at: with questions or suggestions. Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=16152