BPI TECH BRIEFS (January 11, 1994)

Biopreservation, Inc. is a human cryopreservation services provider and
brain cryopreservation research and development company.  While BPI's
structure is a for-profit one, it is our intention to foster the growth of
knowledge and scientific advancement as rapidly as possible.  In order to
facilitate these objectives we have decided to begin publishing technical
and nontechnical material of relevance to the field of human
cryopreservation in a rapid fashion.  While some of our research will
remain proprietary or will be undisclosed until patenting, much of what we
do and learn will be appropriate for immediate dissemination.  Aside from
the previously stated objectives of advancing the state-of-the-art we
strongly believe that such disclosures will enhance our position and
profitability a goal which we also believe is a worthy one.

Below is an introduction to BPI, its facilities and its staff.  Future BPI
TECH BRIEFS (BPITB) will concentrate on specific technical problems in
the field of human cryopreservation and related disciplines.

Individuals wishing to submit material to BPI for inclusion in BPITB
should fell free to do so.  Anyone wishing more information about the
company should contact Michael Darwin with *specific* questions.  Since
BPI does not provide services directly to the public we do not have
promotional literature.
 
                  Introducing BioPreservation 
 
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                      The best equipment
             The most highly qualified personnel
     A serious commitment to suspended animation research 
 
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                         Introduction 
 
     BioPreservation, Inc. (BPI) is a for-profit company 
which specializes in medicating, perfusing, and cooling 
people who are under the legal control of cryonics 
organizations such as CryoCare Foundation and The American 
Cryonics Society. We offer unmatched experience and expertise 
in the clinical procedures that are essential for optimum, 
controlled cryopreservation. 
 
                      Preliminary Steps 
 
     Working closely with the patient's cryonics 
organization, we take an active role to insure that long 
before cryopreservation procedures actually begin, the 
elements which are critical to a high-quality outcome are 
firmly in-place.
 
     Ideally, the first step is to insure that the patient 
has exhausted all medical options to remain alive with an acceptable
quality of life at the present time. Our medical staff reviews the
patient's medical records, consults with other experts, and reviews
appropriate medical databases in an attempt to determine the patient's 
likely prognosis and current therapeutic options.  The patient is informed
of the results of this search and therapeutic options, if any are
available, are discussed.

     Since cryopreservation of humans is not yet a recognized 
medical procedure, we cannot begin cryopreservation while the 
patient is still alive. However, there is much that we can 
and will do to insure that when legal death is pronounced, 
within the limits of current techniques, the patient will 
receive the best possible care and minimal injury.
 
     If the patient has in fact exhausted the resources of 
contemporary medicine and is terminally ill, we begin working 
with the patient's cryonics organization, family, and medical 
personnel, to achieve the following objectives: 
 
     * We establish a rapport with the treating medical staff 
and secure their informed cooperation, as much as possible, 
to facilitate the patient's cryopreservation under optimum 
conditions. 
 
     * In conjunction with the patient's treating physician, 
the patient, and (where appropriate) the patient's family, we 
begin a program of pre-cryopreservation medication to 
minimize the effect of the ischemic interval (i.e. the period 
where the person experiences deep shock/no blood flow) which 
inevitably occurs between the time legal death is pronounced 
and cryopreservation procedures begin. 
 
     *  Working closely with the patient's cryonics 
organization, we evaluate the patient's home, hospital, 
hospice, or nursing home to insure that facilities are 
adequate to begin the initial phases of cryopreservation. For 
instance, we will try to insure that the patient is physically 
accessible, in a room that is big enough, with no obstacles 
such staircases or impossibly narrow hallways. Again, in 
conjunction with the patient's cryonics organization, we also 
work to establish a liason with a local mortuary so that the 
patient can be moved promptly and legally to our facilities 
in Southern California for cryoprotective treatment and 
cooling to -79 degrees Centigrade. 
 
     *  If the patient wishes to remain at home for pre-
suspension (i.e., terminal) care, we work with the patient 
and the patient's family and cryonics organization to insure 
that the patient is enrolled in a home-hospice program in 
which the hospice personnel and local authorities (where 
appropriate) are adequatedly informed regarding special needs 
such as prompt pronouncement of legal death and avoidance of 
medico-legal autopsy (postmortem dissection). 
 
     *  When the patient's condition reaches the point where the
need for cryopreservation is imminent, we move our equipment, 
medications, and personnel as near to the patient as possible 
and stand by on a twenty-four hour basis, ready to perform 
cardiopulmonary support after legal death is pronounced. 
Mechanically augmented CPR is used initially. Subsequently, a 
heart-lung machine supports circulation, oxygenation, and 
cooling of the patient's blood. The blood is then replaced 
with Viaspan R(1) organ preservation solution. The patient is 
cooled to a degree or two above freezing and is then moved 
via air or surface transporation (depending upon distance and 
logistics) to our facility in Southern California for the 
next phase of the treatment. 
 
     Our standby team includes a perfusionist, emergency 
medical technicians, and other certified cryopreservation 
transport technicians. Our Medical Director (a licensed 
physician) is also available for standbys and has 
considerable experience dealing with attending physicians, 
hospital/hospice/nursing home administration, and other 
medical staff. 
 
                          Perfusion 
 
     In a spacious operating room at our facility, 
the patient is perfused with a cryoprotective solution that 
will minimize tissue damage when the temperature is 
subsequently lowered and deep cooling to -79 degrees 
Centigrade is begun. We are better equipped than any 
comparable organization to control and monitor the lengthy, 
complex procedure of cryoprotective perfusion. 

       Our duties end when the patient's temperature dips to 
-79 degrees Centigrade (the temperature of solid carbon 
dioxide, or "dry ice"). At this point, the patient's cryonics 
organization supervises transfer of the patient to the 
service provider responsible for long-term care at -196 
degrees Centigrade (the temperature of boiling liquid 
nitrogen). 
 
                           Research
 
     At BioPreservation, we recognize that the techniques of 
cryoprotective perfusion are imperfect at present and must be 
actively refined and improved as rapidly as possible. In 
pursuit of this goal, we are conducting privately funded research 
in conjunction with several other companies aimed at 
perfecting a reversible method of cryopreservation for the 
brain (suspened animation). 

     In canine Total Body Washouts (TBW), we have revived 
dogs successfully after they have been perfused with a 
preservative solution (perfusate) and held without vital 
signs for up to 5 hours at 3 degrees Centigrade. This 
research is unmatched by any other laboratory in the world, 
and it has already yielded important results leading to 
significant improvements in the techniques of cryoprotective 
perfusion. 

     Perhaps most importantly, we have made a major 
commitment to understanding and defining the limitis of 
current human cryopreservation techniques, and we are working 
to improve them further. Currently, we are undertaking an 
aggressive research program with both dogs and rabbits, 
hoping to improve the degree of fine structural preservation 
of the brain and eliminate the gross mechanical injury from 
cracks or fractures which develop in tissues that are cooled 
to liquid nitrogen temperature. The first phases of this work 
have already resulted in significant improvements in our 
human cryopreservation protocol. The complete results of 
these studies (including a variety of evaluations of brain 
structure at the organ, tissue, and molecular level) should 
be available by mid-1995. 
 
                         Our Facility 
 
     BioPreservation is located in Southern California, 
forty-five minutes from downtown Los Angeles and five minutes from the
international airport at Ontario, California. The modern, 7200 square
foot building is larger and better equipped than any comparable facility
specializing in human cryopreservation. It is divided as follows: 
 
     Function                              Square Feet
 
     Operating room                               1400
     Laboratory                                   1000
     Materials prep/Sterile processing             300
     Rest area for staff                           200
     Operating room staging area                   450
     Ambulance bay, workshop, storage             3000
     Library/Conference room                       200
 
     Operating Room Details

     The 1,400 square foot operating room is equipped with 
cardiovascular perfusion and monitoring equipment of the same 
type found in state-of-the-art medical centers. Blood gases 
and electrolytes (including glucose, sodium, potassium, 
calcium, chloride, pH, pO2, pCO2 and hematocrit) can be 
monitored continuously while the patient is perfused with 
cryoprotectants. Precise knowledge of these parameters 
provides important information for the long-term benefit of 
the patient and short-term benefit of others who may follow. 
Such feedback is critical to improving the quality of the 
cryopreservation treatment. 
     Monitoring is carried out with an in-line CDI 300 
extracorporeal monitor and a Nova Stat 5 blood 
gas/electrolyte analyzer. The CDI 300 provides continuous 
feedback, enabling minute-by-minute adjustment of critical 
blood gas parameters without the usual lag time which occurs 
with off-line blood gas equipment. The Nova Stat 5 provides a 
double-check of blood gases and allows for electrolyte 
measurements during perfusion. Additional back-up capability 
is provided by an IL1302 blood gas system, an IL282 co-
oximeter, and a Nova 1 electrolyte system. 
     The composition of sweep gas being delivered to the 
oxygenator during bypass is precisely controlled with the use 
of a Cobe Laboratories air, oxygen, CO2 blender which is 
monitored by a Critikon Oxycheck oxygen concentration 
monitor. 

     The operating room is equipped with three compete sets 
of cardiothoracic surgical instruments, numerous non-
cardiovascular procedure instruments sets, and linens, 
drapes, and sterile disposable supplies to allow for the 
conduct of TBW cerebral resuscitation research and human 
cryopreservation at or beyond the level of any major 
university. 
 
                     Laboratory Equipment 
 
     A Kodak Ektachem DT system measures clinical blood 
chemistry factors such as albumin, ALKP, AST, ALT, CK, CKMB, 
Creatinine, GGT, LDH, lipase, ammonia, amylase, total 
bilirubin, BUN/urea, lactate, magnesium, phosphorus, and 
total protein. Using the Ektachem system, a researcher has 
most of the analytical capabilities of a commercial clinical 
laboratory, in-house, twenty-four hours a day. 

     Our facility is also equipped with a wide range of 
supportive equipment including osmometers, oncometers, 
refractometers, centrifuges, pH meters, microscopes, 
balances, autoclaves, shaker baths, controlled temperature 
baths, and so on, to facilitate biomedical research. 
 
        Ambulances/Mobile Advanced Life Support System 
 
     Two ambulances are available at all times. (No other 
cryopreservation organization has a backup ambulance.) One is 
a late-model vehicle manufactured by Leader Industries, 
extensively modified to accomodate a custom-fabricated Mobile 
Advanced Life Support System (MALSS). This unit provides 
rapid, controlled cooldown externally and internally (by 
perfusion). It also monitors blood gases and pH and contains 
its own independent power supply. 
     The MALSS is equipped with a Michigan Instruments 
Thumper closed-chest heart-lung resuscitator so that CPR can 
be reliably delivered as a bridge to the initiation of 
extracorporeal support. The MALSS is currently configured to 
run the Sarns hollow-fiber membrane oxygenator/heat exchanger 
for extracorporeal oxygenation and cooling. 

      The second ambulance, a van-type unit, serves as back-
up for the first and is equipped to respond to a local 
emergency if the primary vehicle is out in the field on a 
standby. 
 
                        Staff Quarters 
 
     To enable true twenty-four-hour capabilities, our 
facility includes comfortable sleeping quarters for up to six 
support staff. 
 
                       Cryopreservation
 
     To facilitate cryopreservation studies, excellent 
equipment and consumables are available for isolated 
cryoprotective perfusion of brains, kidneys, and whole 
animals. A range of cryogenic refrigerators and temperature 
monitoring and control equipment is available, including a 
wide array of large- and narrow-mouth cryogenic dewars for 
liquid-nitrogen storage of specimens as well as a Revco Ultra 
Low -115C freezer which allows for fracture-free storage of 
organs and small animals. 
 
                       Work in progress
 
     We are currently constructing automated systems that 
will give us precise control of the introduction and removal 
of cryoprotective drugs and the cooling of humans to -79 
degrees Celsius. 
 
                          Personnel
 
     Our personnel have extensive experience in either deep 
hypothermic canine perfusion, cerebral resuscitation 
research, or both. 

     Medical Director: Steven B. Harris, MD. Dr. Harris is 
board certified internist and gerontologist with extensive 
ICU and Emergency Room experience. In addition to being a 
professional gerontological researcher, Dr. Harris has also 
served as physician and participated extensively in canine 
deep hypothermia experiments sponsored by 21st Century 
Medicine, using various bloodless perfusion protocols. 
     Team Leader:  Michael Darwin, CRT.  Mr. Darwin is a 
certified hemodialysis technician with over 20 years 
experience in deep hypothermia research. Mr. Darwin served as 
President of the Alcor Life Extension Foundation from July of 
1982 to February of 1988. He was Alcor's director of Research 
from 1988 to 1991, and is responsible for the development of 
many of the transport and perfusion techniques currently used 
in human cryopreservation today. Additionally, Mr. Darwin has 
authored numerous technical papers and two textbook/procedure 
manuals on human cryopreservation and asanguineous perfusion 
procedures. Mr. Darwin is also director of research for 21st 
Century Medicine's canine TBW and cerebral resuscitation 
research projects. 

     Scribe: Sandra Russell, BS (Biochemistry/Cell Biology). 
Ms. Russell is a professional educator and businesswoman who 
serves as scribe/perfusion monitor and blood gas technician. 
She has extensive experience performing data acquisition and 
ICU care in 21st Century Medicine's canine TBW and cerebral 
resuscitation programs. Ms. Russell has also had extensive 
clinical experience as a cardiac technician in a large 
hospital where her duties included ECG testing/analysis, 
treadmill monitoring, and Holter monitor analysis. 

     Facilities Manager: Paul Wakfer, BASc (Engineering 
Physics), MA (Applied Mathematics). Mr. Wakfer's duties are 
logistical support for research personnel, in-house equipment 
technician, and business manager. He has participated also in 
21st Century Medicine's canine TBW and cerebral resuscitation 
experiments. 

     Respiratory Therapist, Equipment Technician: Michael 
Fletcher, RT. Mr. Fletcher is a respiratory therapist, 
respiratory equipment technician, and an EEG technician. Mr. 
Fletcher's duties are equipment maintenance during research 
(he has worked as a mechanic and sheet metal worker and has 
extensive shop/fabrication/mechanical skills), and 
respiratory therapist during in 21st Century Medicine's 
canine research programs. 

     Engineering Support: Mark Connaughton, MS (Professional 
Engineer). Mr. Connaughton has participated in canine TBW 
research performing blood/perfusate analyses, and is 
currently involved in the design of computer controlled 
perfusion software and hardware for BioPreservation. 

     Primary Perfusionist: Paiboon Plookvongpanit, CCP. Mr. 
Plookvongpanit is a certified clinical perfusionist with 
experience in canine TBW research and canine cerebral 
resuscitation experiments. Mr. Plookvongpanit is director of 
clinical perfusion at Riverside Community Hospital and has 
extensive experience in both research and clinical perfusion. 

     Perfusionist: Shawn Shermer, BS. (Physiology). Ms. 
Shermer has 6 years' experience as operations manager in the 
largest contract biomedical research facility in the Western 
United States. In this capacity, she functioned as 
perfusionist, surgical assistant, animal care technician, 
recovery room nurse, and ICU nurse. She has also participated 
in deep hypothermia/TBW experiments employing dogs, primates, 
and sheep. Ms. Shermer participated in (and was laboratory 
manager for the facility during) the testing and development 
of the Johnson and Johnson hemopump intra-aortic turbine 
pump. 

     Perfusate Preparation: Larry Wood, BS (Biochemistry). 
Mr. Wood's duties are perfusate preparation and surgical 
assistant. Mr. Wood has long experience in drug and 
parenteral preparation and has participated in most of 21st 
Century Medicine's canine TBW and Cerebral Resuscitation 
experiments. 

     Scrub Nurse: Faye Smith, RN. F.S. is a surgical scrub 
nurse at a large community hospital. She has over 10 years' 
experience and has served as a consultant in sterile 
processing and sterile technique. Mrs. Smith has also served 
as scrub nurse during most of 21st Century Medicine's canine 
research operations. 

     Circulator: Candy Wood. Candy Wood has been trained as 
circulator in-house during 21st Century Medicine canine 
experiments.