2001 CMVSM.P. Ruka, The Manual-Organ/Tissue Transplantation - For Humans and Animals Benefit
- 1 -
Abstract in the Layman Language
(450-word Summary for the Press Release)
In view of the shortage of organ donors, the efforts of establishing sources of organs in sufficient numbers from e.g. the animal donor (pig), increase in the number of small animal patients diagnosed with uremia and/or diabetes and the pet owners increased demand for the treatment of these diseases by organ transplantation, the increased interest of medical, veterinary, and biological professionals and the public in the medical, social, and ethical issues of using animal(s) for medical research, the Cambridge Center for Medical & Veterinary Sciences Inc.(CMVS) will implement its mission statement and goals in the form of establishing clinical, teaching, (applied) research and diagnostic programs in the field of organ transplantation, for the benefit of humans and animals health.
These programs are going to be implemented by (I) cooperation with selected medical transplant center(s), and (II) developing and establishing the Hospital with its three distinct accredited and certified facilities in the form of:
(a)Companion Animal Hospital (CAH, a referral hospital is planned to be constructed in Greater Toronto Area (GTA) following the human hospital standards, and licensed under Dr. Ruka's veterinary small animal transplant license, the phase one) referred in the CMVS materials as the Hospital-CAH,
(b)Swine Research Wing (to-be licensed by the CCAC, CVO, etc.,and constructed in the Cambridge area in the 2nd phase), and
(c)Wing or Department of Xeno-Graft Transplantation into Human Recipients (to-be constructed in the Cambridge area in the 3rd phase).
Theofficial name, the plan of these facilities, and the programs are in the process of being established in accordance with all applicable Local (Institutional), Municipal, Provincial and Federal regulations and guidelines.
These programs are not and will not infringe in any form on other veterinary, medical and biological schools/colleges and their undergraduate and post-/graduate programs or other veterinary hospitals, as this Hospital-CAH and it's programs will exclusively devote 100% of its time to the field of organ transplantation. At present such programs, as presented and proposed by the CMVS, are not offered by any of the pharmaceutical companies or colleges/universities (public or private) in North America.
Currently, the CMVS, is in the process of searching for, from the public and private sectors, an initial loan or investment in the amount of U$16.5 million (to generate a return of interest on the protected investment to the CMVS of approximately U$1.5 million/year), that includes a basic injection of seed money in the amount of U$1.5 million. The ultimate goal, however, would be to raise additionally an approximately U$85 million within the next 5-10-year period (from the moment of its first initial investment) to create the company's financial asset in the amount of close to U$100 million for the purpose of generating a return of interest on the protected investment in the amount of about U$10 million/year (working capital).
For Further Information or Requests, Please Contact:
Dr.M.P.RUKA
55 Yarmouth StreetSuite no. 204 GuelphOntarioCanadaN1H 7R4
Tel.: / Fax: (519) 763-9192 E-mail:
The CMVS Executive Summary *
- The Purpose of the Program:
This is the new concept of first national and international affiliation, in the field of organ transplantation, among veterinary, biological, human medical and related disciplines and professions under a single patronage named as the Cambridge Center for Medical & Veterinary Sciences Inc. (CMVS), that is planned to be constructed in Central Ontario (the fastest growing region in Canada from the economy and population point of views), in the form of the Hospital (with its three distinct accredited/certified facilities), in accordance with the Canadian Government requirements.
At present, the Cambridge Center for Medical & Veterinary Sciences Inc. (CMVS), the company open for an investment (% of ownership), located in Central Ontario, Canada, is in the process of searching for, from the public (a loan from the Canadian Government) and private (e.g. philanthropist, Venture Capitalist) sectors, an initial investment in the amount of U$16.5 million (to generate a return of interest on the protected investment to the CMVS of approximately U$1.5 million/year), that includes a basic injection of seed money in the amount of U$1.5 million. The ultimate goal, however, would be to raise additionally an approximately U$85 million within the next 5-10-year period (from the moment of its first initial investment) to create the company's financial asset in the amount of close to U$100 million for the purpose of generating a return of interest on the protected investment in the amount of about U$10 million/year (working budget).
II.The CMVS (Figure 8):
This is the first effort, in the history of the human and veterinary transplant medicine, of bringing a group of veterinary clinical uremic and diabetic dogs and cats patients as a new clinical animal model in the treatment of naturally occurring diseases such as uremia and diabetes by organ transplantation. The knowledge gained and the results obtained from the treatment, established techniques, approved protocols and projects will be immediately applied into human transplant recipients.
The CMVS is a clinical, teaching (with the plans of building a private College/University), research with diagnostic laboratories Center including its functional programs (to-be carried out in the accredited or licensed facilities), regulations and services established and developed for the purpose of assessing the strategies to be undertaken by professionals in their fields of expertise (veterinary, human medicine, biology and others) in organ and tissue auto-, allo-, xeno-transplantation for the public health - the benefit of humans and animals.
These clinical, teaching, research and diagnostic programs, as indicated above, in the field of organ and tissue transplantation are going to be implemented by (I) cooperation with selected medical transplant center(s) in Canada (negotiations in progress) and (II) developing and establishing the Hospital with its three distinct facilities as functional arms (=accredited/certified) in the form of:
(d)Companion Animal Hospital (CAH, a referral hospital planned to-be constructed in GTA following the human hospital standards, and licensed under Dr. Ruka veterinary small animal transplant license, the phase one) referred in the CMVS materials as the Hospital-CAH;
(e)Swine Research Wing (to-be licensed by the CCAC, CVO, etc.,andconstructed in the Cambridge area in the 2nd phase), and
(f)Wing or Department of Xeno-Graft Transplantation into Human Recipients (to-be constructed in the Cambridge area in the 3rd phase).
Theofficial name and plan of these facilities are still in the process of being established (and pending on investment), in accordance with all applicable Local (Institutional), Municipal, Provincial and Federal regulations and guidelines including the College of Veterinarians of Ontario (CVO), Canadian Council on Animal Care (CCAC), Animal for Research Act (ARA), Ministry of Health, Ministry of Sciences, Ministry of Education & Training, Ministry of Agriculture Food & Rural Affairs, and others.
These teaching, clinical and research programs are not and will not infringe in any form on other veterinary, medical and biological schools/colleges and their undergraduate and post-/graduate programs or other veterinary hospitals in Ontario and Canada, as this Hospital-CAH and it's programs will exclusively devote 100% of its time to the field of organ transplantation. The all spectrum of clinical veterinary transplant services, oriented into the treatment of uremia and diabetes will be offered to approximately 1.8 million of uremic and/or diabetic companion animals requiring our services (=1.46% of the total number estimated on approximately 120 million dogs/cats living in the U.S.A. and Canada). In the second stage of the development of transplant programs at the Hospital CAH, the clinical transplant programs of treatment of heart or liver end-stage diseases are planned to be instituted, as well. However, at present, due to focusing of our priorities mainly on setting up the programs directed into the treatment of uremia and diabetes, which are planned to be established within the first 5 years of the Hospital-CAH, additional transplant programs addressing needs for e.g. treatment of heart or liver diseases by transplantation are not included in our current materials.
- Veterinary Market Analysis (see Figures 1-3, 5,6 and 8):
The American Veterinary Medical Association (AVMA) has reported that there is approximately 110-120 million dogs and cats (of which approximately 50% are dogs and 50% are cats) living in the U.S.A. (country with a population of approximately 250 million people) that corresponds with such information available in all sort of Almanacs, additionally showing steadily increase in the animal population by approximately 1% - 2% per year, that corresponds well with the growth of human population (Figures1B and 2B)
(a)The Patients -
It has been reported that the prevalence of renal failure in cats and dogsfor all ages of examined animals was observed in 16 cases for every 1000 cats examined (n=1,056,000 uremic cats of total 66 million animals), and in 9 cases for every 1000 dogs (n=540,000 uremic dogs of total 60 million animals), seen/examined by a veterinarian for all reasons (=per year)1. Additionally, others suggest that the chronic renal failure occurs more often than acute renal failure in dogs and cats and is probably the most common disorder affecting the kidney2.
Incidence of diabetes mellitus for the cat and dog is similar and may vary from 2 to 2.5 cases for every 1000 cats examined (n=132,000 cats of total 66 million animals=cats in North America), and 2 cases for every 1000 dogs(n=120,000 dogs of total population estimated on approximately 60 million dogs), seen/examined once a year by a veterinarian for all reasons3,4.
It means that,in North America, there is approximately 1.5% of dogs and cats diagnosed every year with uremia and/or diabetes mellitus (n=1.8 million of companion animals which are uremic and/or diabetic of the total number estimated on approximately 120 million dogs/cats living in the U.S.A. and Canada) that will require our services, using variety of sources of organ donors for transplantation (Figures 5 and 6).
Moreover, based on Dr. Ruka's preliminary non-published studies carried out at the Ontario Veterinary College, it has been shown that in the period from 1984 to 1994, a total of 949 clinical cases of uremic/diabeticdogs/catswere admitted (without any advertising campaign through the mass media) to the Veterinary Teaching Hospital (VTH) at the Ontario Veterinary College (OVC), University of Guelph in Guelph, Ontario. Approximately 40% - 50% of these uremic/diabetic dog/cat patients were euthanized or died because of their end-stage kidney disease or diabetes could not be treated by conventional medical means. In addition, over the period of 2 years, from 1992 to 1994 there has been observed an increase in the number of uremic and diabetic dogs and cats admitted to the VTH at the OVC by about 44.55% and 74.35%, respectively.
Furthermore, in view of an impressively high success rate of kidney transplantation in humans and general awareness of the population in a very successful long-term survival rate of patients receiving other organs such as heart, pancreas, liver, or lungs, there has been observed a steadily increasing demands by the pet owners (dogs and cats) for kidney transplantation to treat end-stage kidney disease (with 70% of support for organ transplantation, Figure 7). Our services of veterinary clinical organ transplantation in pets at the referral Hospital-CAH (accredited by the CVO, CCAC, Ministry of Agriculture, etc.) will target the owners of approximately 2.5 million dogs/cats in Central Ontario of which 1.5% are uremic and diabetic animals that will need the veterinary assistance.
(b) The Population -
Central Ontario, is the fastest growing region in Canada from the economical and population point of views, with a population at present exceeding 7 million people and with 42 colleges/universities, in the radius of 150 km of Cambridge. Central Ontario is the only region with such demographic congestion of population in Canada.
The CMVS programs are not going to be limited to the Ontario region only, but will be offered to the owners of approximately 120 million dogs and cats in Canada and the United States as well (including introduction of franchising system), of which 1.5% (=1.8 million) will need our services.
It is expected that the knowledge gained and the results obtained from these established techniques and protocols, and the projects planned to be carried out by the Hospital-CAH in the cooperation with other universities and medical centres will be immediately applied, initially in the form of pre-clinical trials, to human transplant recipients.
(c) The Education & Teaching -
The CMVS programs will also be offering teaching services for under-/ post-/ or graduate students who are going to be trained in the field of transplant medicine/surgery on clinical uremic/diabetic dogs and cats, as well as all procedures of admission, treatment, surgery and post-transplant follow-up, which are going to be established at our Hospital-CAH, and carried out following the standards required in human hospitals.
The Hospital-CAH will be a fundamental structure of our private college/university system built for the purpose of offering a new very attractive curriculum (for the potential students) with the privilege of issuing its own diplomas and/or degrees, in accordance with the recent Canadian Government regulations (privatization of education in Ontario, issued under the legislation of Post-Secondary Excellence and Choice Act from 2000; former Bill 132).
These teaching programs are planned to be continue at the Swine Research Wing (preliminary name) where students will learn with hands-on on all aspects of organ procurement, storage, preservation, immunosuppressive protocols, etc. including all procedures related to supplying the human recipients with the animal-donor (pig) organs and tissues, targeting a medical market in North America (but not limited to) due to the shortage of organ donors.
It is expected that over the next decade additional 30,000 - 40,000 students each year (due to elimination of Grade 13 from the high schools, children of boomers', general increase of interest in young people to participate in a higher education system, scholarships, etc.) will seek options of educational challenges at the university campuses in Ontario, which at the present (with their curriculum and capacities) are not able to cope with such demands.
(d) The License -
In 1995, for the first time in the history of veterinary medicine, the College of Veterinarians of Ontario(CVO) issued to Dr.Ruka a veterinary license (limited) as aVeterinary Small Animal Organ Transplant Surgeon (License No. # 4796), in recognition and acknowledgment of: (a) the pet owners increased demand for the treatment of end-stage of organ diseases (where the organ/tissue replacement therapy would be apply as one of the several methods available); (b) significant increase, over the period of last 10-15 years, in the number of small animal patients diagnosed with uremia and/or diabetes; (c) the need for such high standard services to be provided for companion animals in the form of treatment of the end-stage of organs and old age diseases by highly qualified personnel in especially accredited for such purposes facility; (d) the need of higher education in this particular field that will be available to the public and professionals; and (e) Dr. Ruka's documented international academic experience and expertise in the field of small animals organ and/or tissue transplantation.
IV.Medical Market Analysis (Figures 3 and 4):
In the medical field the CMVS services, through its accredited/certified facility(s) and programs, will reach the group of transplant recipients (our potential customers as well) with end stage of organ disease (kidney, pancreas, heart, liver, lungs, etc.) on waiting lists. Following the 1999 UNOS’ statistical analysis it has been shown that 5.4% of patients died while awaiting for the suitable organ. The most realistic solution to this shortage of human organs, besides the efforts of extending the donor pool, will be xenotransplantation using the pig as the universal organ donor. The ultimate goal, however, can be achieved only by employing the technique of tissue cloning, and supplying the transplant recipients with perfect organs and to avoid any events related to the episodes of rejection and/or drugs cytotoxicity.
Today in Canada more than 1,000 patients (22,000 patients per 250 million population world-wide await organ transplantation) are still waiting for kidney transplantation, a number that steadily increases each year (with a waiting period, for patients, of approximately 12 months, or even longer). It has been reported that in the United Kingdom 25% of heart patients died on the waiting list, and in the U.S. 2,800 heart patients died while waiting for a suitable donor. In the U.S. between 1986-1993 the number of patients awaiting for their first organ transplants increased three fold, but at the same time the number of available donors increased by only 14% (in Canada by 15.5%). The recent 1999 UNOS’ data reports that there are 63,635 recipients registered on the waiting list.
V.The CMVS Marketing and Services Strategies (Figures 8 and 10):
The gist of this program offered by the CMVS, for the purpose of being successful in this competitive environment, is to build the Hospital-CAH, a core of the CMVS proposed educational system combining teaching, clinical, research and diagnostic programs in the field of organ transplantation, the fundamental elements essential in establishing a private College / University (under the legislation of Post-Secondary Excellence and Choice Act from 2000; former Bill 132, offering the unique curriculum in the form of services to the professionals/public, and courses in comparative medicine/surgery of three main species: dogs, cats, and human beings including additionally pigs), for the generations to come.
Marketing of the referral Hospital-CAH services/programs to the public, with or without conjunction of the CMVS programs/services using mass media system, pet food/pharmaceutical companies, or other entities/systems/vehicles to be used for our services/products promotion/advertisement (including direct marketing of such services to the veterinarians) will be carried out in a very cautious, very well organized and strict manner in accordance with the Canadian/International marketing and the College of Veterinarians of Ontario (CVO) regulations, where the direct contact with the CVO must be established and maintained.