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The history of fetal precursor cell transplantation is actually a history of fetal precursor cell xeno-transplantation.

It was not until the late 70-ies of the last century when human fetal tissue transplantation (‘allotransplantation’) began in the U.S.S.R. and from there spread into some other communist countries, i.e. Yugoslavia, Hungary, German Democratic Republic, Peoples’ Republic of China.

In the late 80-ies Hana Biologicals, a public corporation based in Alameda, California, began procurement of human fetal tissue transplants in cooperation with a human fetus collection company in Philadelphia, PA. After U.S. FDA approved clinical trial of treatment of type 1 diabetes mellitus by transplantation of cells produced by Hana Biologicals failed, all cell transplantation activity ceased in the U.S. until 2001.

This idea was born a long time ago.

Papyrus of Eber - 3,000 B.C. - described preparation of medications from animal organs.

Susruta1,400 B.C. (Mesopotamia, today Irak) – prescribed ingestion of sex glands of young tigers as treatment of impotence.

Hippocrates470 – 410 B.C. – carried out transplantation of frog skin to treat man.

Aristoteles384 – 322 B.C., and Plinius the Elder -23 – 79 A.D., described preparation and use of animal and human organ extracts for human treatment.

Paracelsus (Theofrastus Bombastus of Hohenheim) – 1493 – 1541 - wrote in his book: ‘Heart heals heart, kidneys heal kidneys’ and “Like heals like”, i.e. he discovered organospecificity, one of the scientific principles of modern fetal precursor cell transplantation..

Hooke1663 – discovered a cell.

Schleiden1838 – discovered that cells are the structural basis of all plants.

Schwann1839 – discovered that cells are the structural basis of all animals, not only of plants.

Hunter1771 - and Berthold1849 – proved substitution effect of implanted sex glands on a castrated cock.

Brown-Sequard1889 – presented to the fellow members of French Academy of Sciences report on self-treatment by implantation of rooster sex glands for revitalization (as an elderly widower he re-married a much younger woman that caused problems which he, the most famous physiologist of his era, resolved). This was the first documented case of cell xeno-transplantation in the history of medicine. Immunosuppression was unknown then.

Virchow1821 –1902, father of modern pathology, stated that “all life stems from cells”, and that “there is no life without cells”. Or, in other words, that ‘cells are bearers of all life’.

Carell1873 – 1944, father of cell biology, (first U.S. Nobel prize winner, in 1912, for discovering technique of surgical suture of blood vessels), succeded in keeping a tissue culture of chick embryo cardiomyoblasts alive indefinitely, as long as the tissue culture medium was replenished at regular intervals by another containing a small amount of the same embryonic cells. Actually his tissue culture was allowed to expire after 34 years.

Cushing 1869 – 1939, one of the fathers of neurosurgery, was also the most important endocrinologist of all times due to his pioneering research on pituitary hormones and their relations to hormones of hypothalamus, adrenals, and other peripheral endocrine organs. Niehans credited Cushing with some of his ideas that were included in the concept of cell therapy / cell transplantation.

Landsteiner1900 – discovered blood groups, thus making blood transfusion safe, without immunosuppression. Blood transfusion was the first widely used method of cell transplantation in clinical practice.

Kuttner1912 - succesfully transplanted human adult thyroid tissue to another patient after thyroidectomy. Immunosuppression was unknown at that time.

Voronoff1910 – began to widely use xeno-transplantation in clinical practice. His research on transplantation of animal (monkey) testes to aging men caught attention of media and brought him notoriety. Unfortunately monkeys are carriers of syphilis (which is harmless to them) and thus his patients acquired a dangerous disease, for which there was no treatment at that time. Today by following U.S. FDA and WHO rules on manufacturing xeno-transplants this kind of disaster would be impossible. No immunosuppression was used then.

Niehans1982 – 1971 – doctor of Lutheran theology and doctor of medicine, decorated hero of WW1 and WW2, a member of Papal Academy of Sciences, an illegitimate child of the last German Kaiser, developed between 1920 and 1931 ‘cell therapy’* that was defined by him as a transplantation of freshly obtained animal fetal tissue fragments of various, in principle all, organs for treatment of man.

In 1927 he succesfully used implantation of fresh calf pituitary tissue fragments for treatment of pituitary dwarfs. In 1929 he treated patients with chronic polyarthritis by a similar method with success.

In 1931 he was asked to save life of a woman dying of tetany due to accidental removal of all parathyroid glands during total thyroidectomy by a famous surgeon. As there was no time even for the usual minor implantation surgery, P. Niehans took surgical scissors and chopped down the animal parathyroid glands obtained from the slaughterhouse so that it would pass through an injection needle, and implanted the tissue fragments thus obtained with syringe and large-bore needle. The patient survived and lived for another 21 years. Thereby ‘cell therapy’ was born, created in a life or death situation, without any research or scientific discussions. This genius clinician treated more VIP’s of our world than any other physician alive or dead. He did not use any immunosuppression.

In 1954, during ‘Therapy Week’ in Karlsruhe, Germany, around 5,000 physicians packed the auditorium, standing in vestibule and halls, in order to listen to his lectures. As a result of his teachings and that of his most glorious followers: SCHMID, STEIN, SCHMIDT, KMENT, NEUMANN, HOEPKE, v. LANGENDORFF, BERNHARD, LETTRE, LANDSBERGER, ANDRES, WOLF, GIANOLI, CAMERER, and others, as many as 5 million patients were treated by cell therapy ( more than 4 million of that in Germany), of which around one million was treated by live cell transplants. Afterward the definition of cell therapy was enlarged to include the use of preserved cells for treatment.

In 50-ies P. Niehans received one night visitors from an insulin-maker Eli Lilly Co. with a check for U.S. $ 1,000,000,- to induce him to stop his attempts to find a treatment of diabetes mellitus by cell therapy. (To find a treatment for diabetes mellitus and cancer by cell therapy was his lifelong obsession.) After he refused, pharmaceutical industry began to systematically attack cell therapy. After 1956 all publications about cell therapy /cell transplantation stopped in U.S., and from that time no U.S. medical school library kept any German medical journals known to publish articles about cell therapy / cell transplantation, or books.

In 1987 German government banned the sale of preserved celltherapeutica in pharmacies, but when it attempted to ban cell therapy altogether in 1997, i.e. fresh cell therapy / cell transplantation, it failed. German Supreme Court ruled on February 16, 2000, that fresh cell therapy / cell transplantation is safe, and overturned the attempted ban.. This decision means that cell therapy has continued to be permitted in Germany and thereby in the entire European Union.

Filatow – 1875 – 1956 – father of transplantation of cornea, while developing his method came in 1933 across an idea to use implantation of fragments of human placenta to improve results of corneal transplantation. Implantation of human placental fragments became the most popular biological therapeutic method to-date, worldwide, known under numerous names, usually that of the clinic owner. No immunosuppression has ever been used.

Kasakow – in 1925, based on the method of Tuchnow, developed treatment by cell hydrolysates, which became well known in USSR. Subsequent to the death of the deputy chief of NKVD (predecessor of KGB), allegedly as a result of such therapy, Kasakow was sentenced to death, his governmental institute eliminated and all writings locked up for generations by KGB in a library of banned literature, until partially discovered by BCRO in 1993.

Shumakow – 1979 – published in a peer reviewed journal about the success of cell transplants prepared by tissue culture in the treatment of a female with severe complications of insulin dependent diabetes mellitus, without immunosuppression; the patient was well for 21 years without any additional cell transplantation.

Bio-Cellular Research Organization (BCRO)

In 1976 the author’s father died in communist Czechoslovakia by a horrible death due to 9 consecutive strokes over a period of 18 months, as a complication of epidemic of serum hepatitis, developed during his unnecessary hospitalization for type 2 diabetes mellitus, that he suffered from 1949. As a result of the nine strokes, his brain was severely damaged and he had to be kept in a netted bed on a closed psychiatric ward. The author did not know anything about his illness, because his mother did not tell him, until 4 months after the death of beloved father. During her subsequent visit to U.S. she told him all the details. Then he he made a postmortem pledge to his father, to give all his free time and talent to find the treatment, which would saved his life. Three years later he found it: fetal cell transplantation.

This highly talented surgeon, with 24 years of busy surgical practice, had ultimately to give up his private practice in Los Angeles and Orange County to honor the pledge to his father. Today he is convinced that he ‘got it, indeed’. It has been amazing to observe what can be accomplish therapeutically with BCRO fetal cell transplantation in so many “incurable/untreatable” diseases, in all fields of medicine and with an absolute safety(!): to this date not a single complication was reported, from all five continents where his patients have been treated.

In 1981 the author learned of New Hope Parents Association, U.S. non-profit foundation of parents of handicapped children (mostly due to genetic and chromosomal diseases), which used to invite Prof. Dr. Franz Schmid, a German pediatrician and the biggest expert worldwide in zellentherapie (cell therapy), to the U.S. 3 to 4 times a year, to teach the parents of such children and give them consultations in German zellentherapie treatment, which such children got in Aschaffenburg, West Germany. New Hope fought with the U.S. FDA for the German zellentherepie to be allowed in the U.S., but to no avail. This is how the author met in 1981 Prof. Dr. Schmid in Los Angeles, who agreed to became his teacher, until his untimely death in 1997. He was a Professor of Pediatrics of Heidelberg Medical School, a general director of State Pediatric Hospital in Aschaffenburg, unofficially the ‘German Center for Zellentherapie’, and the Chairman of both committees on zellentherapie of BundesGesundheitAmt (BGA), the German counterpart of the U.S. FDA.

Subsequently the author started a cooperation with Biotonus Clinique Bon-Port in Montreux, Switzerland, a well known clinic of "zellentherapie", where he was going to do bio-cosmetic surgery (combination of cell therapy with surgical rejuvenation of face and neck), launched at that time in West Germany. In September 1988 the just created BCRO began its work in the field of fetal cell transplantation in Yugoslavia, where the colleagues decided to base the project in the Medical School in Sarajevo, today Bosnia/Hercegovina. That decision proved ominous, since in early 1990 the project was terminated by civil war.

In October 1989, the author proposed in writing to the USSR Minister of Health Prof. Dr. Chazov, to create in Moscow a joint venture between Bio-Cellular Research Organization (U.K.) and the USSR Ministry of Health under the name ‘International Institute of Biological Medicine’ (IIBM), primarily to do a clinical and a basic research on human fetal cell transplantation. Surprisingly a positive response arrived in about one month.

Author's pledge to search for therapy/ies that would have saved his father's life, began at first by haphazard review of the medical literature, and then it became more systematic, in about two years time. It started to focus on the study of German school of cell therapy, and then by close work with Prof. Dr. Franz Schmid and other leaders in this field in Germany between 1981 - 1997. Finally organization of a major clinical research project of International Institute of Biological Medicine (IIBM), a USSR/Russian joint venture, created in 1991 by Bio-Cellular Research Organization (BCRO)(UK), as 51% shareholder, together with a division of the USSR Ministry of Health Care, as a 49% shareholder, in the human fetal precursor cell transplantation. After the fall of USSR in December 1991, 49% of shares of IIBM were taken over by the Ministry of Health and Health Care of Russian Federation.

In 1989 U.S.FDA permitted HANA Biologicals, a division of Corp., a clinical trial of treatment of type 1 diabetes mellitus by human fetal cell transplantation, while continued its attitude that animal fetal cell transplantation is a ‘Frankenstein treatment'. The author spoke with medical director of Hana Biologics three times, since he thought that it would be easier to do research in U.S., but it was clear that their approach was completely wrong. In 1991 they published their results of treatment of 51 diabetic patients of type 1 with 0% success rate!

IIBM project in USSR began in 1990 with participation of two best hospitals in Moscow, one smaller one, only for the leaders of the country, second one for upper echelons of "nomenclatura", then the huge main military hospital, and the 16 USSR/Russia top medical centers/research institutes, all in Moscow and the vicinity.

'"Kremlin Hospital" to serve the ABSOLUTE TOP and Central Clinical Hospital for the TOP echelons of Russia, IIBM had a permit to treat there by FCT Russian and foreign private patients;

'Burdenko Main Hospital of Russian Army (Prof.Dr. Briusov, Chief Surgeon): use of FCT in surgical tx of gunshot wounds caused by new bullets used in Chechnya war;

Research Center of Pediatrics (Academician Studenikin): use of FCT in tx of genetic diseases, M.Gaucher, chron. hepatitis, aplastic anemia, cirrhosis of liver, cerebral palsy, cardiomyopathies, inborn brain damage;

Pediatric Hospital of Moscow First Medical School (Academician Baranov): use of FCT in tx of collagen diseases;

Research Center of Endocrinology (Academician Dedov): use of FCT in tx of nanismus, congenital hypothyroidism;

First Republican Pediatric Hospital (Prof.Dr. Burkov): use of FCT for transplantation of human fetal testis;

Rehabilitation Center of First Moscow Medical School (Prof.Dr. Grinio): use of FCT in tx uf muscular dystrophies;

Research Center of Transplantology and Artificial Organs (Academician Shumakov): use of FCT in tx of complications of type 1 diabetes mellitus, male infertility, hypo-endocrinopathies;

Sklifasovsky Research Center of Emergency Medicine (Prof.Dr. Lebedev): use of FCT in tx of Parkinson's disease, aphasia after severe brain injuries, post cerebrovascular accident damage;

Moscow Burn Center (Prof.Dr. Smirnov): use of FCT for tx of infected (surgical) 3rd and 4th degree thermal burns;

Research Center of Medical Radiology in Obninsk (Academician Tsyb): use of FCT in tx of post therapeutic irradiation damage of soft tissues;

Research Center of Biophysics (Academician Iljin): use of FCT in tx of accidental irradiation damage;

Research Center of Obstetrics, Gynaecology and Perinatology (Academician Kulakov): use of FCT in tx of early menopause of various etiologies (incl. castration), intrauterine brain damage (early tx), endometriosis, infertility

Research Center of Human Reproduction (Prof.Dr. Vasiliev): use of FCT in tx of male infertility and impotence;

Priorov Central Institute of Traumatology and Orthopaedics (Prof.Dr. Shaposhnikov): use of FCT in surgery of inborn severe deformities of upper extremity;

Helmholtz Research Center of Ophthalmology (Prof.Dr. Brovkina): use of FCT in tx of myopathy of eye muscles, perforation of the eye after therapeutic irradiation;

Fedorov Eye Research Institute (Prof.Dr. Fedorov): use of FCT in tx of retinitis pigmentosa, diabetic retinopathy;

Research Institute of Medical Technology (Prof.Dr. Belych): biodegrable biopolymers saturated with FCT for plastic&reconstructive and orthopedic surgery;

First Stomatological Institute: use of FCT in tx of severe parodontosis.

Treatment of complications of type 1 diabetes mellitus by human fetal cell transplantation was an official USSR project, which was launched in 1970’s by Research Institute of Transplantology and Artificial Organs of USSR Ministry of Health, which reported its success already in 1979 in peer-reviewed medical journal. The great success slowed down to a near standstill in 1991 due to breakdown of USSR and their inability to obtain a sufficient quantity of human fetuses of the second trimester to make fetal cell transplants for all of patients that required such treatment. Their juvenile diabetes mellitus project was revived by IIBM by using human fetal cell transplantation, and also animal fetal cell transplantation prepared from rabbit fetuses. It was a real breakthrough in medicine because juvenile diabetes mellitus was and is the "real killer", particularly in children. (Prof.Dr. Paul Niehans, the "father of cell therapy", was obsessed his entire life to find the treatment of juvenile diabetes, without luck.)

The excellent results of the USSR (and IIBM) in the treatment of complications of type 1 diabetes mellitus were in 1999 submitted to U.S. FDA in order to obtain license applications for Bio-Cellular Research Organization to run clinical trials of treatment of untreatable diabetic retinopathy, nephropathy, lower extremity arterial disease and polyneuropathy as a complications of diabetes mellitus type 1 by BCRO method of fetal cell transplantation (of rabbit origin) in U.S.A. BCRO received FDA-IND numbers 8214 for FCT treatment of advanced retinopathy, 8217 for FCT tx of advanced retinopathy, 8218 for FCT tx of lower extremity arterial disease and 8219 for FCT tx of polyneuropathy, all as a complication of diabetes mellitus type 1, but U.S. FDA was not giving in U.S. pharmaceutical industry was not interested in finding the solution!

Up until the submission of our four IND applications (prepared by the author personally) in February 1999, the cooperation with U.S. FDA, from its inception in November 1996, was friendly, except for the fact that U.S. FDA did not want, for no good reason, to allow a study of use of IIBM fetal cell transplantation treatment of brittle diabetes in children, where both USSR and IIBM had 90% success rate. From February 1999 on, it was increasingly clear that U.S.FDA will never permit the BCRO clinical trials in the U.S., that would confirm the excellent results of USSR transplantologists and IIBM. The 31 members of the Health Committees of U.S. Senate and Congress ignored our loud complaints, that U.S.FDA was evaluating the results of our fetal cell transplantation using criteria for drugs of chemical origin(!) (it was completely illogical to try to evaluate a treatment by transplantation of live fetal cells by using the rules made for drugs of chemical origin!).

In 1994 TASS(press agency of USSR) issued a press release for Arabic world and soon I was invited to U.A.E., Qatar and Kuwait to examine first group of patients in those countries, which then sent their patients for treatment in Moscow. Later in 1994 - 6, IIBM was treating patients regularly in their biggest governmental hospital in Doha, Qatar.

The first Symposium on transplantation of human fetal tissues, under the sponsorship of the Russian Academy of Medical Sciences, on December 4-7, 1995, was a large success, with 34 scientific presentations in 7 sections: general introduction: state of affairs and the perspectives, treatment of diabetes mellitus by human fetal cell transplantation, its use in neurology, in gynaecology and andrology, in pediatrics, in surgery, in other fields of medicine. - Over 500 case histories of human fetal brain cell transplantation, with individual(!) combination of fetal brain cell transplants, via lumbar puncture, in patients with various incurable neurodegenerative diseases, and post cerebro-vascular accidents, etc., with respective success rates, were given in 6 different reports of neurology section.

International Institute of Biological Medicine and the author personally, invited six months in advance, the U.S. medical journal “TRANSPLANTATION PROCEEDINGS” to record all four days of the IIBM conference in Moscow for December 4-7, 1995, and publish the same in their usual way. We were assured in writing by the President of their Editorial Board, that they would come to Moscow to record the entire proceedings and to publish the same.

Two days before the start of the conference the President of ‘Transplantation Proceedings’ informed the author that the staff of ‘Transplantation Proceedings’ will not come to Moscow, to do recording, and will not publish any of the presentations, without any explanation of the reason(s).

Because of exceptionally difficult conditions in Russia at that time, caused entirely by the U.S., and the belief of Mr. Gorbachov that the U.S. (and the Pope John Paul II) will play the clean game, and his dissolution of USSR, conference organizers were unable to find local resources to handle the recording and publishing of all proceedings on such a short notice. As a result, manuscripts of presentations of all authors were never published.

From 1997 on the author has been on his own, due to death of his teacher Prof.Dr. Schmid, as he had no other teachers, since the previous senior generation of the fellow members of the German Association of Zellentherapie either died or retired, in the same period of time, so that the author himself became a lecturer and ‘healer’ (as declared in 2015 by a Swami Chakradhari of Hindu religion), treating patients by ‘BCRO fetal cell transplantation’, of rabbit fetal origin, all over the world.

In 2009 there was a 1-day medical conference dedicated to the author in Moscow, during which his picture was on the screen at all times, accompanied by slogan "E.Michael Molnar, M.D., the father of 'kletochnaia terapia' in Russia". I did not know about it, I was informed from the Russian friends present.

After leaving Russian Federation in 1997, because the of the status of Russian Federation as a U.S. colony, which included eventually complete control of medical research by U.S. Big Pharma, did not allow continuation of IIBM project, the author organized further research differently, by lecturing and educating physicians and to perform BCRO live fetal cell transplantation himself worldwide: at the beginning in Germany, Switzerland, Italy, Czech Republic, Slovakia, Austria, Mexico, where also German cell therapy was known. The results of treatment of patients with incurable/untreatable diseases of central nervous system, which was completely new, were very much appreciated in those countries.

Then from February 2006 on, the author was lecturing, do consultations and treatment by BCRO fetal cell transplantations, in multiple cities of many Asian countries: in China, (as well as in Hong Kong and Macau), Taiwan, in many cities of south/southwest of India, in all major cities of Indonesia (on islands of Sumatra, Java, Bali) Thailand, Philippines, Malaysia, Singapore, Australia, Turkey, Panama, Nigeria, South Africa, Mexico, Switzerland, Austria, Italy, Czech Republic, Slovakia. The whole day lectures of 9 hours duration were conducted by the author also to the groups of local physicians in South Korea, Cambodia, Georgia, Egypt, Kuwait, Romania. Subsequent to U.S. FDA issuing regulations about preparation of cell, tissue and organ xeno-transplantations in September 1997, BCRO completed the development of own method of manufacturing of cell transplants of animal fetal origin, and after filing U.S. Patent application in 1998, began its own preparation of fetal precursor cell transplants, from rabbit fetuses (from own closed colony of rabbits, started in 1973), individually for each patient, in July 1998. BCRO has not discovered a procedure(!) of fetal precursor cell transplantation, it found a method of preparation(!) of fetal precursor cell transplants, of any of 220 kinds of cells that all mammals are made of, for clinical use, that can be implanted with ‘state-of-art’ safety, and without immunosupression(!). Today only about 90 kinds of cells are completely described by science(!) and as such are routinely used for fetal precursor cell transplantation in medical practice. In 1997 BCRO moved its commercial preparation of fetal cell transplantats from rabbit fetuses, raised in a closed colony, as defined by the World Health Organization, by BCRO technique, to Slovakia. After author's departure from the Russian Federation in 1997, the intrathecal fetal cell transplantation (from closed colony of rabbits) has been utilized by him to treat adult (past the age of 12 years) incurable/untreatable diseases of brain and spinal on most of continents, and that included successful treatment of Alzheimer’s disease and other dementias. The 'rabbit fetal cell xenotransplantation’ has been completely safe. For children, up to the age of 12, the same 'fetal cell transplants’ have been used as well, but without requiring intrathecal implantation (via lumbar puncture). The best for the reader would be to immerse himself ( or herself) in the deep study of https://bio-cellular-research.com. Besides that the only latest textbook in this field of medicine in English has been the author’s “Fetal Precursor Cell Transplantation. BCRO Fetal Precursor Cell Transplantation”, 980 pages, posted as a new edition on amazon.com in January 2015.

NOTES: Anglophone medical literature uses the term ‘cell transplantation’, while German literature has used the term ‘cell therapy’ (‘zellentherapie’) for implantation of tissue fragments of animal fetal origin. Russian literature uses the term 'kletochnaia terapia' (which means the same as German 'zellentherapie') for human fetal cell transplantation. - German law does not recognize the term ‘cell transplantation’ and U.S. FDA banned the ‘cell therapy’ sometimes in 1956.

There is a discrepancy between terms ‘cell therapy’ and ‘cell transplantation’ when it comes to an implantation of tissue fragments of animal fetal origin. ‘Cell transplantation’ includes only ‘fresh cell therapy’ as in the original definition of Niehans, but not the use of preserved cells (preservation by lyophilization causes cells to lose cell membrane and thereby they are no longer live, preservation by freezing - as it used to be done in those days – leads to death of 85 – 95% of cells, mostly during thawing process). Today in German ‘cell therapy’ (‘zellentherapie’) means use of animal preserved cells or cellular material for treatment, while ‘fresh cell therapy’ (‘frischzellentherapie’) means the use of freshly obtained (up to 2 hours after death) fetal tissue fragments of animal origin for therapeutic implantation.

Fetal precursor cell transplantation was introduced into clinical practice officially by Prof.Dr. Paul Niehans in 1931 and has historically preceded organ transplantation by several decades. It shall dominate the medicine of 21st century.

Brief summary of author’s experience with fetal precursor cell allo- and xeno-transplantation.

This method of treatment has been around for over 90 years in several different countries: Germany, Switzerland, France, Italy, Spain, Austria, USSR, etc. Political, philosophical, professional, language, and other barriers have caused the absence of scientific communication in this new field of medicine between two pioneering countries: Germany and U.S.S.R. The author succeeded in overcoming this barrier and accomplished a symbiosis between 'zellentherapie' and 'kletochnaia terapia' under 'BCRO fetal precursor cell transplantation'. '''''' Germany has been the only country in the West where various methods of cell therapy / transplantation have been widely used since 1950-ies. The form of this treatment known as ‘fresh cell therapy’ (’frischzellentherapie’), has been used to this date. In February 2000 the Bundesverfassungsgericht (‘German Supreme Court’) in Karlsruhe, case number: 1 BvR 420/97, ruled positively about a continuous approval of this therapeutic method. Since over 800,000 patients have been treated by fresh cell therapy in Germany during the past 65 years, this was quite an impressive statement. (Another more than 4 million patients have been treated during this time by frozen and lyophilized ‘cell-therapeutica’, registered in West Germany until 1987.)

In 1984 the Ministry of Health of U.S.S.R. issued ‘Recommendations on the Method’ (the same type of document as ‘U.S. FDA regulations’), dealing with cell transplantation that amounted to the official approval of this treatment. VI.BIBLIOGRAPHY [76] It confirmed a completion of a major pre-clinical and clinical research in this field in the U.S.S.R.VI.BIBLIOGRAPHY [78], which led to the successful treatment of a patient with complications of IDDM (by fetal precursor allo-transplantation), already in 1979, and thereafter thousands of other juvenile diabetics and patients suffering of other incurable/untreatable diseases). Since the Ministry of Health of U.S.S.R. put its Research Institute of Transplantology and Artificial Organs of the Ministry of Health of U.S.S.R. (‘RITAOMH’) in charge of this work, and the transplantologists, ‘big surgeons’, were much more interested in organ transplantation than in ‘just simple injections of cells’, the method did not attract much attention within the socialized health care system. Only after IIBM became active in the new Russian Federation in 1991, the fetal cell transplantation became known as a therapeutic method also outside of the ‘Fourth Department’, health care system for ‘nomenclatura’ (‘apparatchiks’), and the ‘Third Department’, health care system in the military, and was included in the list of approved therapies by the Ministry of Health Care of Russian Federation, health care system for the general public, and received a governmental code.

By the decree of the Minister of Health of Russian Federation of November 1994 it is now a duty of a diabetologist in Russia to refer a diabetic patient for cell transplantation, if indicated. VI.BIBLIOGRAPHY [77]

By the time of its first international symposium in December 1995, in Moscow, IIBM treated by fetal precursor cell allo- and xeno-transplantation around 3,000 private patients with a variety of diseases, besides many thousands treated under various clinical research projects. The number of Russian patients, that were treated free of charge under different research projects, was never kept and is impossible to estimate. In the span of 4 years (1993 - 6) IIBM treated the same number of registered patients as 12 top Soviet research institutes since 1979.

The major contribution of IIBM was its never presented work, carried out together with the staff of RITAOMH, in which the clinical results of cell transplantation by fetal precursor allo- and xeno-transplants were compared. This study proved the overall superiority of fetal cell xeno-transplantation. The main reason was a much better quality of the animal (rabbit) source of fetal cell transplants. While the animal (rabbit) material could be obtained always (!) perfectly fresh, i.e. cells were 100% live when planted onto the tissue culture medium, the same could hardly ever be stated about human fetal cells, where for obvious reasons there was always a delay between the time of death and the dissection of human fetal cadaver, usually quite substantial, so that the viability of cells at the time of their planting onto the tissue culture medium was questionable. For clarification, ultimately there were 12 major medical research institutes of transplantology in 5 different republics of U.S.S.R. involved in cell transplantation. It should be noted that medical science was organized in U.S.S.R. under a ‘pyramidal principle’, i.e. in each field of science there was a central U.S.S.R. institute in charge for the whole country, for example RITAOMH in transplantology, and then there were central institutes in each field of medical science in charge in each of 15 republics of U.S.S.R.

Although RITAOMH was in overall control in the transplantology, the main institutes of each Republic had a latitude in their actions. Initially, some of them were carrying out only fetal precursor cell allo-transplantation, while others only fetal cell xeno-transplantation, with bovine or porcine fetuses as sources of transplants, and some of these institutes carried out both fetal precursor cell allo- and xeno-transplantation. Ultimately human fetal precursor cell transplantation was abandoned by all of them in favor of animal fetal cell transplantation. Among 12 research institutes involved in cell transplantation, only RITAOMH switched from bovine and porcine fetuses to the rabbit fetuses as a source of cell xeno-transplants, and that began in 1987. The change of the of source of fetal cell transplants coincided with the fall of communism, and of the U.S.S.R., which caused a major breakdown of Russian medical science, medical industry, and health care, with a subsequent decrease of medical publication activity as well.

As a result, there is much less published material about the cell xeno-transplantation with fetal and newborn rabbits as a source of transplants, as compared with bovine and porcine fetuses. In ‘Bibliography’ are included also dissertations for the degree of ‘Candidate of Medical Sciences’ (‘Ph.D.’), and for the degree ‘Doctor od Medical Sciences’, mandatory for all future professors, carried out under the roof of RITAOMH, summaries of lectures from the various ‘All-U.S.S.R.’ congresses on cell, tissue and organ transplantation: 10th All-U.S.S.R. Symposium on Organ Transplantation, 1985, in Kiev (now Ukraine), 4th Congress of Ukrainian Endocrinologists, 1987, in Kiev, Symposium on Transplantologic Methods of Treatment of Diabetes Mellitus, 1988, in Riga (now Latvia), 3rd All-U.S.S.R.Congress of Endocrinology, 1989, in Tashkent (now Uzbekistan), 11th All-U.S.S.R. Symposium on Organ Transplantation, 1990, in Lvov, (now Ukraine), and from the symposiums at RITAOMH in Moscow, as well as from the yearly International Symposia ‘Transplantation of Endocrine Pancreas’, organized by the Institute for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center, Belgrade, Yugoslavia.

Without deep knowledge of human and veterinary embryology, cytology of human diseases (never studied in medical schools), detailed pathophysiology of human diseases, availability of BCRO fetal precursor cell transplants will be of no value for the treatment of patient with incurable/untreatable disease(s).

WHAT WAS HAPPENING WITH IIBM while all this hard work in fetal cell transplantation project was going on.

International Institute of Biological Medicine was officially created between branch of USSR Academy of Medical Sciences, the Research Institute of Care of Mother and Child, and IIBM, in early December 1991 in Moscow. - On December 28, 1991 USSR collapsed, USSR did not exist anymore, and there was Russian Federation and its government in its place. Remaining 15 republics of former USSR became independent entities. U.S. President Reagan and the Pope John Paul II convinced President Gorbachov, that USA and the West help restore Russia to prosperity in no time. "Just sign at the dotted line".... Mr. Gorbachov trusted this two "very honest gentlemen".

In January 1992 Mr. Yeltsin, a hopeless chronic alcoholic, appeared on the scene as the only candidate for President. He was elected, un-opposed. Six months later food stores in Moscow were empty. People were forming lines waiting long hours for delivery of bread. Food was found on the black market only, for hard currency. Hunger was apparent.

Shortly thereafter CNN cameras appeared on the roof of buildings surrounding the parliament. Just a few days later the word was out that Vice-President Ryzhkov organized a military coup against the President. By agreement there was a vote of one group of elite military units against vote of opposing units. President Yeltsin won by narrow margin. Our daughter was a freshman at Tufts University then. One of her subjects were "international studies". She wrote a paper about the situation in Russia where she used the facts that I told her. I was spending in Moscow every other week, so my information was more up-to-date than that what U.S. press was feeding American public. She got C- on her paper with a comment of her professor "where did she hear such a non-sense". I wrote the professor and the Chancellor of Tufts University. Three months later U.S. media were filled up with stories about heavy drinking of Russian President Yeltsin, making him unfit to fulfill his duties. Interestingly enough, that President Reagan and Pope John Paul II did not know about it when to every citizen of Russia this was not any news.

Fortunately, already in USSR, I passed a tough investigation because of earlier my departure from communist Czechoslovakia to U.S., so that I was trusted do organize the fetal cell transplantation project in new Russia. In April 1992 IIBM announced publicly its existence by press conference in Moscow. At that time the construction of our laboratory for preparation of human fetal transplants was already finishing and the futuristic facility for liquid nitrogen freezing was already built by Soviet/Russian cosmic industry, so that in August 1992 we could start with the preparation of fetal cell transplants for patient treatment and fill our liquid nitrogen freezer.

In September we announced the launching of FCT treatment of patients in December 1992. Decision was made to start with treatment of Down syndrome in children from specialized hospital for chidren with congenital and chromosomal diseases in Moscow, what was done in honor of Prof.Dr. Schmid, the father of such treatment.

In October Prof.Dr. Kulakov received a letter from Stern, largest magazine in Germany, requesting an interview by its Moscow correspondent. It was scheduled for the day of inaugural treatment of first Down syndrome patient in early December 1992. Everything turned out well on that day, including our interview with Stern. But they played a dirty game. They dressed up their photographer in the nursing uniform of Russian Institute of Obstetrics, Gynaecology and Perinatology of Russian Academy of Medical Sciences, witch was a mammoth institution, the largest of its kind in the world, and he gained an illegal entry as a nurse. All night he took a photographs of patients in very busy obstetrical unit. In the morning he left, not recognized as an intruder

Two weeks later my daughter, a 14 years old student International School of Geneva, Switzerland, the official school of United Nations, established in 1921, came home with a recent issue of Stern in her hand, sobbing. On the entire front page of Stern was a photograph of 6 months old stillborn, dead in the uterus for a few days, displaying all colors of long dead human body, held by feet with the hand of old, obviously busy, mid-wife. A horror! Inside of the issue was the interview by me and our Russian director, many negative comments from the West and multiple shocking pictures of patients, fully recognizable, taken without permission. This was a bomb for everyone in Russia. This was how the West was going to play the game with post-Soviet Russia. Thank you, Pope John-Paul II and my former neighbor, the U.S. President Reagan, in the Riviera portion of Pacific Palisades, California!

After that, in the first three months of 1993, all major European magazines published negative stories about IIBM and Russia. I did not see a majority of them. I was a "star" in all of them, unwanted. In June - as a re-bound, Russian team from Mosfilm asked IIBM for cooperation in production of a rebuttal. We agreed. I appeared in person, speaking Russian for the first time in my life. That documentary film was shown on large screens in major squares of all European cities. This film was actually made for Spiegel TV, the largest private TV producer in Germany!

Our Bio-Cellular Research Organization had its German branch in Munich, its head was my close friend Reiner Oppenheimer. His father was one of those Jewish heroes, who became famous for hunting down in South America the old German Nazis and bringing them to Israeli courts for justice. Reiner found out all about who did that film and all dirty details. He put a stop to this non-sense with the owners of Spiegel TV. He subsequently organized a meeting between the German female producer of that film and myself. It happened in well known old Geneva Hotel Les Bergues. The main restaurant was closed so that we, the lady producer and I, could speak freely for 4 and a half hours. For the last hour the producer cried on my shoulder, deeply apologizing for what she had done to me, to us. She told me that she was given by her bosses my dossier kept by the company in Philadelphia, PA. and she had no reason not to trust everything that was in those documents. Now when she met me in person, she could see that I was totally different than the man described in those documents. She told me that she is determined to tell the truth in new film. Of course, management of Spiegel did not to spend any money on that so they turned her project down, as expected. I met her two more times by her request. She stopped working for Spiegel TV when she was not allowed to rectify her wrongdoing based on the false data provided by her employer. When I met last time at Zurich Airport she already had a new job.

Reiner Oppenheimer visited in Vienna the Founder of Anti-Defamation League, because the action of Spiegel was triggered by my anti-Jewish background, but was firmly told that it was not so. (I was very upset by that accusation, because my paternal grandmother was Jewish, married to a Jewish man, and after his death converted before she was re-married to my Austrian grandfather, who was Catholic. The family, which helped me to escape from communism, was Jewish. I lived in their house in Los Angeles for 7 months, before I passed my licensing exam in California and began to work. "Big Pharma" did not stop there. Just 3 months later I received home a phone call from a man with a last name of old Hungarian noble family: von Szechenyi. He introduced himself as a son of a lady, whom we met at a Caribbean cruise a few months earlier. Her daughter was of the same age as ours and the girls became good friends. Our daughter attended that same year a summer school in Connecticut, where this girl lived nearby and our daughter spent two weekends in their house. Her mother was an Austrian, a granddaughter of a famous Viennese music composer and was divorced from the Hungarian nobleman. He called and asked me for a meeting the next time I came to Moscow. I was going there every other week. This young man handed me his business card, from which I learned that he was an associate producer of CBS "60 Minutes TV show". He asked me if I would not mind to meet with Mike Wallace, who was taping their show in Moscow. I was not particularly avid TV viewer, so I did not know who Mike Wallace was. We met with Mike Wallace the next day. And then every day for the rest of the week. Naturally next day - Wednesday - I immediately realized, what are these people up to.

They interviewed in front of camera - in my presence - the President of Russian Academy of Medical Sciences, Vice-President of Russian Academy of Sciences, both were asked the same question, if they knew me personally, and knew me very well... This were stupid questions, because before I could meet them for the first time, and allowed to get into their inner circle, etc. etc., I was very deeply checked, very thoroughly, by KGB. - Later on I saw the full 60 minutes show about our fetal cell transplantation project - and myself. They did visit Prof.Dr.Schmid in his hospital in Germany as well, and asked him the same question: "Do you know Dr. Molnar and how well do you know him?"

During the week of shooting we treated also a 4-years old Puertorican girl with Down Syndrome, who was later on not recognized by a school psychologist as being born with such a genetic disease, when she entered a regular school at age of 6. This was the result after the recommended four fetal cell transplantations! She was shown on that CBS 60 Minutes and her father was ridiculed by Mike Wallace. Her father wrote me about that with the comment, that if Mike Wallace would cross his path alone just one time, it would be the last time. A few years later I saw on French TV a documentary film apparently done with his approval. Mike Wallace was not his real name. He was a Polish Jew with a typical name: he changed it when he immigrated U.S.A. On that film he was surprisingly candid. He suffered from manic-depressive psychosis, tried to commit suicide three times, underwent multiple long hospitalizations in closed psychiatric ward.... I read in International Herald Tribune, which was one of the most respected papers in the western world, an article which stated that there is only 4,500 people in the world, who would like to murder Mike Wallace, if they could get to him. He was earning 2 million U.S. dollars a year from 60 Minutes Show. If we would have that kind of money for research available to IIBM in Moscow we would accomplish medical miracles. To give them to one sick psychiatric patient in just one year was not correct. Big Pharma is able to earn that money on opioids every second.

In April 1993, our International Institute of Biological Medicine in Moscow was visited by the medical director of Sansum Medical Research Foundation, Santa Barbara, California, who asked IIBM to treat their U.S. patients with advanced diabetes mellitus of type 1, with ncurable/untreatable complications: diabetic retinopathy, leading to blindness, and diabetic nephropathy, leading to kidney failure, requiring hemodialysis treatments 3x a week, and later on kidney transplantation(s), and if failed then death. Under wide U.S. publicity, TV and printed media, with the title of L.A. Times headline stressing the use of ‘Russian rabbit fetal cells’ for fetal cell transplantation, we treated the first group of 24 of those patients on August 1, 1993. It was going to be a cooperation between IIBM and Sansum: IIBM would treat the Sansum patients with our method of FCT, with our fetal cell transplants, that we brought from Moscow in our portable liquid nitrogen freezer, built by Soviet/Russian Cosmic industry and three physicians of IIBM would treat the Sansum patients: I was doing the fetal cell transplantations and two Russian physicians would load the syringes with appropriate fetal cell transplants for each patient. The FCT treatment of 24 patients was uneventful.

When we arrived on July 31, 1993, the L.A. Airport staff was upside down, when the Swiss Air "spilled out" its special cargo, that looked like a huge smoking monster.

(Prior to that, we spent a week in Santa Barbara and Southern California for discussion with Sansum staff, and to get acquainted and sign an agreement about our cooperation. On July 4 holiday we were invited to a large party of Santa Barbara billionaires, who on the spot donated $600,000,- for Sansum Medical Research Foundation, but we received not a dime from that.)

Subsequently there was a complete silence on the part of Sansum although by agreement we were to treat their additional 24 patients in August/September 1993. After some unpleasant written correspondence the manuscript of the article with the results of the treatment of 24 of their patients was submitted by Sansum to "Transplantation Proceedings"(allegedly"). IIBM is in the possession of the manuscript, with corrected names of main authors, mine and that of all Russian colleagues, with detailed analysis of the results of all 24 patients.

Then one year later, L.A. Times in the persona of its chief scientific writer, the very same one, who wrote a long article informing the world about IIBM/Sansum cooperation in July 1993, reported that Sansum Medical Research Foundation organized an international medical conference, to which they invited a variety of international guests with a minimum experience in actual treatment of complications of diabetes mellitus by fetal cell transplantation, but forgetting to invite the author and participating two IIBM physicians. The front page article in L.A. Times classified the whole Sansum project as their own work(!), although the author carried out fetal cell transplantations on all 24 patients himself and all fetal cell transplants were prepared by IIBM in Moscow and brought in to Santa Barbara by a portable liquid nitrogen freezer, built by Russian cosmic industry. The chief scientific editor of L.A. Times was well aware of these facts and was reminded of this by the author in writing, as was the chief editor of L.A. Times(!). Dr. Charles Pedersen, the medical director, and his wife Dr. Jovanovic-Pedersen, the member of the Board of Directors of California Medical Association, submitted the manuscript to "Transplantation Proceedings" without giving the names of the author and other participating Russian physicians, thereby commiting the scientific fraud or theft. The rest of the professionals of Sansum walked away from Drs. Pedersens and organized the continuation of cooperation with IIBM at Los Gatos Community Hospital in Los Gatos, Calif.

On August 1, 1993, a total of 24 U.S. patients with complications of IDDM, predominanly of retinopathy and nephropathy, were treated by IIBM in the clinical facility of Sansum in Santa Barbara, Calif. A manuscript describing the positive clinical results of this trial was submitted for publication to ‘Transplantation’ by medical teams of Sansum and IIBM. It reported on the treatment of 24 patients with Type 1 diabetes mellitus with retinopathy, nephropathy or both, with duration of diabetes of 21±7 years. During 12 months’ follow-up the insulin requirement was significantly reduced by 21±8% (p=0.0260), systolic blood pressure was significantly reduced from 120±17 to 111±13 (p=0.012), and diastolic blood pressure from 78±8 to 72±8 (p=0.005). Total body weights were reduced from 153±30 to 150±28 (p=0.189), and HbA1c from 7.1±1.4 to 6.8±1.2 (p=0.222). Plasma levels of C-peptide increased from 0.06 ng/ml before treatment to 0.186 ng/ml one year later (p=0.01). There was no further progression of retinopathy and nephropathy in any of the 24 patients during the one year follow-up. One female patient became pregnant during this time. VI.BIBLIOGRAPHY [115]

A California company, created by Dr. Bent Formby, Director of Research of Sansum, organized a continuation of these clinical trials in 1995 at Los Gatos Community Hospital, Los Gatos, Calif. VI.BIBLIOGRAPHY [113]. On three different occasions in 1995, altogether 32 U.S. patients with complications of IDDM (n=27) and NIDDM (n=5) were treated by IIBM in the clinic facilities of Los Gatos Community Hospital, again by combined fetal precursor allo- / xeno- cell transplantation, as at Sansum in 1993. During 12 months’ follow-up insulin requirement was significantly reduced by 41±8% (p=0.001), blood glucose levels stabilized from 229±44 mg/dl to 104±21 mg/dl, and plasma levels of C-peptide increased significantly from 0.09 ng/ml to 0.49 ng/ml (p=0.001). Diabetic complications of every patient remained stable, the creatinine clearance of one patient with diabetic nephropathy improved from 39 ml/min to 58 ml/min. (112) The islet cell transplants used in the treatment of all 56 U.S. patients were prepared by IIBM from fetal / newborn rabbits.

A valuable lesson: do not trust - at all - anyone in this age of domination of medicine by U.S. Pharma industry.