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FRAUD IN STEM CELL TRANSPLANTATION

 

In 2000 U.S. printed and visual media suddenly flooded the world with information about ‘stem cell transplantation’, presented as a completely new field of medical science, and “U.S. gift to mankind”. There was no linkage to fetal cell transplantation, or cell therapy, declared in 1931 in Switzerland by western medical historians as new medical treatment after the same took place in 1920’s in USSR. Fetal cell transplantation has been documented in thousands of articles published in German and Russian peer-reviewed medical journals and by treatment of 5 million German patients according to the governmental statistics of West Germany of 1990. (German language does not recognize technical term ‘fetal cell transplantation’, they call the same treatment ‘zellentherapie’ [cell therapy], while in Russian it is called ‘kletochnaia terapia’ [cell therapy] as well.)

As explained further on in the ‘Summary of scientific facts’ fetal cell transplantation, or zellentherapie, always assumed normal quantity of stem cells in each cell transplant.

German ‘zellentherapie’ was banned by U.S. government in 1956, and from that year on one could not find in medical library of any & all U.S. medical schools any issue of the top five German medical journals that usually published all journal articles about ‘zellentherapie’, as well as any medical textbooks in German on ‘zellentherapie’, and the same applied to any medical publications in Russian from the time USSR was born in 1922. It was amazing, that U.S. very recent scientific newcomers to this field, who could never read anything about fetal cell transplantation since 1956, due to the ban, nor attended any meetings of the respective professional societies in Europe or USSR/Russia, were able to launch research activities and instantly publish their discoveries. It is remarkable, that no U.S. publication about ‘stem cell transplantation’ since 2000 has listed any German or Russian reference in its bibliography and thereby was disqualified by the European experts with lifelong clinical experience in this field.

Besides that, the new U.S. stars of stem cell transplantation pronounced that only human embryonic stem cell transplantation is the correct method of stem cell transplantation despite the decades’ old knowledge of all European experts that such treatment is cancerogenic. Likewise they recommended for use an implantation of “universal” stem cells only, contrary to what was advised in Europe over the past 80+ years.

In May 2001, new U.S. President Bush announced, that he will provide federal financing for stem cell research. In August 2001 NIH published extensive information about stem cells and the launch of the project appeared imminent. Then came 9/11/2001 and a complete silence from U.S. government and its medical institutions. Despite that within two years multiple new U.S. stem cell research companies were listed on the N.Y. Stock Exchange, capitalized by U.S. $ 100 to 300 million, notable for one thing: none of them has ever treated any patient by stem cell transplantation!

A public education campaign titled “Stem Cell Transplantation is a hoax of 21st century” was launched in U.S. and spread throughout the world by a special interest group, that triggered suddenly in 2000 ‘stem cell transplantation fraud’, and perhaps was responsible for the ban of German zellentherapie in U.S. in 1956 as well.

Now the magnitude of this fraud reached such proportion, that U.S. FDA has had to take a hurried legal action against multiplicity of U.S. hospitals, clinics and physicians to stop the flood of lies, fabrications and misrepresentations to the public about stem cell transplantation, before this proven valuable treatment for incurable and untreatable diseases becomes discredited. Hopefully this was not the objective of this artificial confusion created by the media.

If you want to learn the truth about ‘cell transplantation’ or ‘stem cell transplantation’ read the scientific explanation of facts, that follow this introduction.



Quick practical advice:

1/ If a physician or salesman shows you a vial with colored water, the vial will not contain any live cells. Cells can be seen with naked normal eye, since they are stuck together in clusters.

2/ If someone shows you a ‘vintage’ vial, covered with dust and cobwebs, containing a beige powder, such vial will not contain any live cells. Live cells do not look like powder.

3/ If someone shows you a vial with frozen cells, ask a question, if they are ‘flash frozen’, or frozen by a computer-controlled freezing system used in infertility clinics. The survival of cells not frozen by a computer- controlled system is minimal, and if the same system is not used for defrosting/ thawing of cells as well, 95% cells will be dead at the time of implantation.

It is rumored that a smuggler convinced U.S. Customs officer and U.S. FDA agent, that the huge quantity of flash frozen cells in her luggage were medicine for personal use for 90 days, supported by a prescription from a Mexican physician, permitted to import to U.S. by the constitutional right of each citizen. When the cells reached U.S.A., they were partially thawed and by the time of implantation they were already rotting.

4/ It is extremely important to investigate the method of preparation of ‘stem cell transplants’ to be used for your treatment.

In winter 2007 the author was invited to Beijing to give a long lecture to a selected audience of medical elite of China. In Q&A session a high officer of Chinese ‘FDA’ stood up, praised the lecturer for finally explaining to him, what cell transplantation is all about. Then he followed: ‘You came just in time. Our government has decided to ban stem cell transplantation. Why? They are exhausted of dealing with one continuous string of scandals.’ Subsequently several hospitals and clinics, heavily promoting stem cell transplantation were closed down. But the ban of stem cell transplantation in China did not take place.

Later on the author proposed to the leader of the Chinese group, a retired big general, well known from history textbooks, to organize the preparation of fetal cell transplants by BCRO method in China. The answer was: ‘No! Our elite would never allow an implantation in their bodies of any cells prepared in China, even though you would personally supervise it. You just keep on preparing fetal cell transplants in Europe and deliver them to China by a currier.’

In 2007 a similar proposal made to governmental VIP’s in Indonesia was turned down, for the same reason.

5/ Beware of fancy, professionally perfect looking web sites marketing stem cell transplantation. Read the text in detail and compare it with the copy of of our BCRO web site. If you wish to study the issues in depth you may decide to consult the textbook for physicians by E. Michael Molnar, M.D., of 982 pages “Fetal Precursor Cell Transplantation, BCRO Fetal Precursor Cell Transplantation”, posted as a new edition on “amazon.com” in January 2015.



6/ If you decide to consult your own physician, make sure that you are talking to a professional, that actually knows something about fetal cell transplantation. Many physicians like to ‘play god’ and wrongly advise their patients about subjects they do know nothing about!

7/ Further on in the summary of scientific facts you will learn that embryonic stem cells are unusable for an actual patient treatment – due to their cancerogenicity - the fact that has been known in Europe and USSR/Russia for several decades’. It already happened in U.S. – the few patients got cancer from embryonic stem cell transplantation.

8/ Further on in the summary of scientific facts you will learn that ‘fetal precursor cells of animal fetal origin are equally effective, and safer, for the patient treatment as those of human fetal origin, so that all difficulties with human fetal cells can be avoided’. Why safer? By U.S. law, all animals used for preparation of fetal cell transplants must originate from ‘closed colony’. In case of rabbits the minimum period that a community of rabbits must live together in closed colony, separated from the rest of the world, is 30 generations, i.e. a minimum of 3 years under constant detailed veterinary observation, before their fetuses could be used for preparation of animal fetal precursor cell transplants. Could human beings be kept that long under such observation, before using their fetuses for the preparation of human fetal precursor cell transplantation?

Next: After euthanasia is carried out in accordance with the established rules of laboratory medicine, the uterus with fetuses from the rabbit female is taken out and immediately passed to the sterile laboratory, where all fetuses and placentas are removed from the amniotic sac without delay. After the veterinary pathologist found at autopsy, that all organs and tissues of each fetus were normal, all organs and tissues necessary for preparation of all fetal precursor cell transplants for the treatment of a specific named patient are collected, all the while the heart is still pumping, blood is pink, fully oxygenated.

To get the human fetal precursor cell transplants one must wait for the natural or induced birth of the second trimester fetuses, necessary for preparation of human fetal precursor cell transplants, which takes hours, so that the fetus has not been receiving oxygen for a long time, and thereby the condition of organs and tissues to be planted onto the primary tissue culture is incomparably worse as compared with animal fetus. As a result, the quality of human fetal precursor cells cannot ever match that of animal fetal precursor cells.

Closed colony’ is described in the educational booklet of the World Health Organization, as well as in the textbooks of E. Michael Molnar, M.D.

9/ Beware that umbilical cord blood, or peripheral blood, contain only fetal cells of hematopoietic and immune systems, as well as a very limited quantity of fetal cells of mesenchyme, rather than fetal cells of 200 – 220 cell types that our body and bodies of all mammals are built from. For that reason diseases of central nervous system, digestive system, urinary system, respiratory system, genetic and chromosomal diseases, etc. cannot be treated by the umbilical cord blood fetal cell transplants, or by peripheral blood fetal cell transplantation!

Umbilical cord blood of human newborn contains hematopoietic and mesenchymal stem cells only, but not ‘Universal Cells’. It is due to the fact, that anglophone ‘peer reviewed journals’ still avoid acceptance of the principle of organospecificity, that all the fraudsters, marketing umbilical cord blood stem cell transplantation, adult autologous stem cell transplantation, implantation of ‘stem cells’ from fatty tissue, can lie to the public, that they are implanting non-existent ‘universal stem cells’, ‘Mother-of-all-Cells’, etc.

Umbilical cord blood or peripheral cord blood fetal cell transplantation are useful only for the treatment of diseases of hematopoietic and immune system.

The medical malpractice, i.e. use of umbilical cord blood cell transplantation for treatment of diseases, where there is not even a theoretical chance to help a patient, has been happening daily.

BCRO clinical method of fetal cell transplantation based on the German school requires, that the treatment be 'individualized' by 'tailoring' the combination of fetal cell transplants used, to a pathophysiology of specific disease(s) of a specific named patient, all that on cytological level, that no physician to-date was taught in medical school and that has always been based on the principle of organospecificity.

In 2007 – 2009 the author was invited several times to southern India to give all day long seminars and lectures on fetal cell transplantation to physicians of many medical schools, governmental medical research institutes, hospitals of Apollo Group Hospital Corporation, as well as to give BCRO FCT treatment to several colleagues suffering from incurable and untreatable diseases.

A 42 years old male physician requested a consultation. He suffered from genetic neurodegenerative disease that his mother and older brother died from already. Trying to save his life he received umbilical cord blood stem cell transplantation at the best hospital in India known for such treatment. He was assured by his treating physicians that such SCT will help him. When his condition was getting worse rather than better, he kept coming back to his colleagues for follow-up visits and continued to be re-assured that he will be fine. When the author consulted the author 18 months later, he was in the pre-terminal state. There was no way to continue lying to him about the fact that umbilical cord stem cell transplantation could not possibly cure or alleviate his illness, the way his Indian colleagues did. The author advised the patient/colleague, that BCRO fetal cell transplantation would stop further progression of his illness, but that would mean just continuous life of suffering, with patient unable to swallow saliva and gasping for each breath. The colleague/patient did not request BCRO fetal cell transplantation.

In the author’s experience this type of medical malpractice, i.e. use of umbilical cord transplantation for treatment of diseases, where there is not even a theoretical chance to help the patient, is happening daily.

10/ Even more serious fraud warning must be issued about the adult autologous stem cell transplantation.

Stem cell auto-transplantation, i.e. therapeutic use of a patient’s own stem cells, tissues, etc., has been introduced into clinical practice only recently. Adult autologous stem cell transplantation has been popularized by media as ‘miraculous treatment’ for one simple reason: as it is a re-implantation of patient’s own cells, the regulatory organs worldwide have no right to interfere. Besides that no immune response will take place after auto-transplantation.

Adult organism contains necessary quantity of stem cells, without which the regeneration and continuation of life would not be possible. The problem with this therapeutic method has been its limited usefulness and minimal effectiveness. Beware that adult autologous stem cells are as old as the patient is, and thereby their biological potential is limited. So if you are 64 years old, your stem cells are also 64 years old. Their therapeutic effectiveness is incomparably lower than of stem cells of a fetus less than 0 years old.

Fetal cells obtained from the fetus are much more numerous than rare adult stem cells, and they possess certain unique properties, such as:

- high level of readiness to differentiate and undergo changes in response to environmental stimuli, or in accordance with their own genetic make-up;

- easy adaptability, due to the plasticity of tissues (including growth, migration, mobility, ability to create cell-to-cell contacts),that in the course of normal fetal development gradually decreases, and finally disappears at the completion of development;

- much more frequent and faster cell division, and proliferation, as compared with adult stem cells, depending upon the type of tissue and stage of fetal development;

- production of large amounts of various biological substances, i.e. growth factors, etc., which facilitate the survival and growth of stem cells after implantation, and stimulate damaged cells, tissues and organs of the host;

- lowered immunogenicity, with a consequently much weaker immune response of the host, as compared with an implantation of adult cells or tissues;

- ability to survive on energy supplied by glycolysis alone, and thus on lesser amount of oxygen, which is important during the preparation of fetal cell transplants, and during the first hours after implantation;

- lack of cell extensions easily damaged during processing of cell transplants.

The clinical effectiveness of fetal cells is incomparably higher than of adult stem cell auto-transplants.

Adult autologous stem cell transplantation is absolutely not a source of ‘universal stem cells’.

Another problem is that source of adult stem cell auto-transplants are the patient’s own tissues. There are only ~ ten types of cells, that one can obtain from patient’s own body with relative ease. It is simple to get blood, skin, connective tissue, fatty tissue, peripheral muscle tissue. To get some other cell types, requires traumatic procedure of needle biopsy of liver, kidney, spleen, thyroid, while for others endoscopy, laparoscopy, excisional biopsy of various magnitudes, or larger invasive procedure, etc. is required. Only female patients can get mesenchyme and placenta at the end of pregnancy. Many cell types, such as those of central nervous system, pituitary, pineal gland, testis, etc. cannot be obtained at all.

In 2009 the author was invited to a private dinner by his two patients in their house. The hosts invited a Ph.D. pharmacologist, who became very wealthy after the sale of his patent to the pharmaceutical industry. He bought an adult autologous stem cell transplantation clinic in Germany. The master of the house arranged a one-on-one conversation between the inventor/clinic owner and an author. The inventor disclosed that he has been a patient in his own clinic. The author asked him about his evaluation of the results of his own adult autologous stem cell transplantation. The first treatment gave no positive result whatsoever. So the medical director of his clinic carried out the second treatment, again with no positive result. The inventor/clinic owner had the third treatment. This time there was a miniscule positive effect. The author asked the inventor/clinic owner, why he kept on repeating the adult autologous stem cell transplantation, when there was no positive effect. He continued useless treatment, because the medical director of his own clinic told him that it is necessary to repeat adult autologous stem cell transplantation five times, before the therapeutic effect becomes apparent. At this point the author interrupted the conversation to avoid social embarrassment.

Due to its minimal effectiveness the use of adult autologous stem cell transplantation for treatment of serious incurable or untreatable diseases is an outright fraud.

11/ The major fraud of late is the use of fat obtained during liposuction as a source of stem cells. All fat suctioned off during liposuction is processed by an equipment over the next two hours whereupon the processed fat, now called ‘stem cells’, is re-injected all over the body to correct body contour deformities.

Between 2007 and 2009 the author was invited three times to Taiwan to conduct all day long seminars about BCRO fetal cell transplantation. In 2008 during one such seminar at the medical school in Taipei, he was asked if he would object when a colleague from Seoul, S. Korea, would during a lunch break speak briefly about a new method of stem cell transplantation.

There was no objection. The colleague was a plastic surgeon. Once the author learned about this new kind of fraud he left the auditorium in silent protest.

Now this fraud has spread from S. Korea throughout the world.

12/ You read a lot about patient’s own blood cells turned by various laboratory procedures into neurons, etc., but therapeutic effect of such hybrids have never been shown in human therapy.

In 2008 the author was invited to participate in a three-day round table discussion about FCT at the Middle Eastern Center of World Health Organization in Cairo, Egypt, organized by the Islamic Organization for Medical Science and World Health Organization. Another invited participant, Prof.Dr. W. Hurlbut, U.S. colleague, from Stanford University Medical School, an expert on the nuclear transfer in human embryonic stem cell transplantation, replied to the question from the audience about a recently published paper reporting on the use of skin from prepuce of a penis as a source for many different stem cells, including that of neurons, in a truly wonderful manner: “You can do all kind of ‘hokus-pokus’ in the laboratory, including changing the appearance of stem cell of one cell type into a stem cell of another cell type. But no one will ever state, what happened when he tried to use such unnaturally obtained stem cell for transplantation to see if it works, i.e. helps the patient.”

One can get very easily fetal cells of all ~200 – 220 cell types of human body and bodies of all mammals are made off, but what is the point to go against Nature and God by forcing the cells to become, what they were not meant to be.

On the other side the media campaign helped the worldwide recognition of fetal cell transplantation by public, and some physicians, as therapeutically very valuable, particularly for those diseases with currently no known therapy, or where the ‘state-of-art’ treatment lost effectiveness. It took only a century since the first patients were so treated in western Europe, or 80+ years since its official declaration in Switzerland as a new item in physician’s therapeutic armamentarium, or 90+ years from its introduction into USSR medicine.

Medical publications by newcomers to this field fail to acknowledge, that during the past 80+ years an ample research has been undertaken, enormous clinical experience gained by fetal cell transplantation treatment of over 5 million patients in Germany alone, and thousands of papers published in ‘peer-reviewed journals’ of countries, where this treatment originated. Medical progress has always been based on the past discoveries, as the structure and function of human body have not changed for thousands of years and will not change for many thousands of years ahead of us. (Claude Bernard, world famous physiologist, in his article in the Bulletin Of New York Academy of Medicine, in 1929, page 997: “Man can learn nothing unless he proceeds from the known to unknown.) Contrary to this principle, all that has been learned about fetal cell transplantation, and reported in medical journals and meetings over the past 100 years, is ignored today like in the Middle Ages, when due to the same attitude the progress of medicine was set back for centuries.

Regretfully, pharmaceutical industry has not found a way to make profit in fetal cell transplantation. BCRO approached in 1991 via our Swiss Representative, Hoffman-LaRoche in Basel, Switzerland, about a cooperation, but there was no interest.

In 1998 Sandoz Inc., later on merged with Ciba-Geigy into Novartis, paid for a financial study by Salomon Brothers titled “Unknown Potential of Xenotransplantation”, that contained a small chapter on cell and tissue xenotransplantation. We discussed a cooperation with Sandoz management - with negative outcome - since 25% of their income was from Sandimmun (Cyclosporin) and BCRO fetal cell transplantation did not require immunosuppression.

Human embryonic stem cell transplantation is spoken about incessantly in the recent English medical literature, even though there is no ‘Mother-of-All-Cells’, or ‘Universal Cell’, from which allegedly are made any & all of ~ 200 - 220 types of cells making up the body of any member of animal kingdom, including ‘Homo Sapiens’. Human or animal bodies are created by union of sperm and ovum, not by a cell line of one embryonic stem cell propagated in the laboratory dish. Only cancerous growth is created that way.

Although U.S. FDA issued guidelines for cell, tissue and organ, xenotransplantation in 2001, and the same guidelines are by a decision of U.S. FDA currently applicable to human embryonic stem cell transplantation as well, for unknown reasons U.S. medical science has ostracized fetal cell xenotransplantation, and U.S. medical schools are focusing on human umbilical cord stem cell transplantation only. U.S. researchers spend all their energy and enormous sums of money on proving that hematopoietic stem cells can become neurons, pancreatic islets cells, basically any & all cells of the body, when it would be so much easier just to use the respective fetal cell transplants of animal origin, with proofs of effectiveness obtained decades ago, and an enormous clinical experience accumulated.

You may get confused when terms ‘stem cell transplantation’ and ‘fetal cell transplantation’ are used side by side in this writing. The term ‘stem cell transplantation’ has been favored by a group of recent newcomers to this field versed in laboratory techniques, but not in clinical practice of fetal cell transplantation. Experienced practitioners of fetal cell transplantation recognized decades ago that fetal cell transplants of various organs or tissues contain all generations of the family of a certain cell type, including those of the fetal precursor cells, i.e. they treated their patients by fetal cell transplantation for many years even though a term ‘cell transplantation’ was not coined yet.

BCRO fetal cell transplantation is not a ‘magic bullet’ either, i.e. a treatment of all known diseases.

At the same time, all patients with diseases with no known treatment, e.g. genetic or chromosomal diseases, or perinatal brain injuries, should be treated with fetal cell transplantation immediately after the diagnosis was made, as time is of essence. Fetal cell transplants prepared lege artis by BCRO method from rabbits from closed colony are safer than baby aspirin, and our experience has proven that there is no harm by trying to treat newborn and infants born with rare diseases, and not be preoccupied by a lack of medical reports or even an exact diagnosis.

There is no competition between ‘standard’ treatment of a disease as published in a U.S. ‘peer-reviewed’ medical journals and fetal cell transplantation. For example, type 1 diabetics must be treated by insulin alone until they develop complications; at that time fetal cell transplantation has to be added, as insulin alone cannot control the progression of retinopathy, nephropathy, peripheral arterial disease, etc., toward blindness, kidney failure, gangrene, impotence, etc. This was declared in 1930 by Alexis Carrel, U.S. Nobel Prize winner.

Fetal cell transplantation was developed primarily by brilliant clinicians responding to a challenge by patients, advised by their physicians that the standard medicine had nothing to offer as a treatment of their illness(es).

Many problems associated with the use of human embryonic cells in medicine have been easily resolved by using fetal cell transplantation of animal fetal origin to help patients suffering from deadly incurable, or untreatable, diseases. Therapeutic use of cell transplantation of animal fetal origin in ~ 1 million patients over 80+ years has accumulated sufficient data to assure public that this treatment is not dangerous to an individual or to mankind.

The above number of 1 million patients represents over 99% of all patients that have received ‘real’ fetal cell transplants to-date.

There are no incurable diseases only those that we do not know how to cure yet. Used properly fetal cell transplantation will lower the number of incurable or no longer treatable diseases.



Summary of scientific facts:

Cell transplants can be manufactured for clinical use from fetuses of any member of animal kingdom, from Homo Sapiens to fish.

All 200 – 220 kinds of fetal cell transplants can be obtained from animal sources.

Xeno-transplantation means a transplantation of live cells, tissues, or organs between the species, in our case from animals to humans, or reverse.

Allo-transplantation means the transplantation within species, i.e. from a man to a man, or from horse to a horse, etc.

The described scientific data explain why it has been possible to implant cell transplants prepared from fetuses of sheep, cattle, pigs, horses, rabbits, and probably other mammals, in over 5 million documented patients over the past 80+ years, without any fatality or other serious consequences for individual patients or mankind.

BCRO has been preparing cell transplants from rabbit fetuses.

Immunosuppressionto use it or not to use it with fetal cell transplantation – has been a subject of heated arguments among physicians practicing this field of medicine for the past 30+ years.

European physicians have never used immunosuppression after cell transplantation, even of cells of animal fetal origin, because they observed in their clinical practice, even when primary cell culture was not used for preparation of animal fetal precursor cell transplantation that

  • allergic reactions were infrequent (incidence less than 5%), 

  • anaphylactic shock was very rare, and 

  • allergic reactions never caused death of a patient(!),

but they used a premedication by antihistamins and cortison.

This was established beyond any legal doubt by the investigation ordered by German Supreme Court in the case # 1 BvR 420/97.

Since in Europe ~ 5 million patients have been treated by various forms of cell transplantation, mostly of animal fetal origin, and none of them received immunosuppression after implantation, there was hardly any need to search for scientific proofs. “Res ipsa loquitur! (Facts speak for themselves!)”

There are many published medical reports originating mostly from USSR official governmental research project on treatment of complications of type 1 diabetes mellitus by cell transplantation on hundreds of patients, showing that changes of laboratory parameters of the immune system function before and after fetal precursor cell transplantation are minimal & statistically not significant.

Until we learn what life is, and many philosophers believe that it will never happen, and thus cannot explain many aspects of the function of living bodies, we have to be satisfied with the fact that implantation of ‘state-of-art’ fetal precursor cell transplants does not cause untoward immune or allergic reactions.

Long term immunosuppression is not only dangerous to the patients, it is also detrimental to the fetal precursor cell transplants, because these are very young cells, enormously sensitive to any toxin, and indeed immunosuppressants are highly toxic!

The controversy should have ended when BCRO presented the existence of its method to the U.S. FDA in 1999 in our four IND license applications

BCRO method of preparation of fetal cell transplants individually for each patient incorporates all pertinent requirements of PHS Guidelines on Infectious Disease Issues in Xenotransplantation” of January 19, 2001 (Federal Register, Volume 66, Number 19, pages 8120 – 1), which is the final version of the same regulation issued initially as a ”Draft” on September 23, 1996 (available from Federal Register under 61FR49920).

On February 16, 2000, by its favorable ruling in the case 1 BvR 420/97, the German Supreme Court ('Bundesverfassungsgericht') re-affirmed that the permission for this type of treatment, in medical practice in Germany since early 50-ies, could continue.

This decision of German Supreme Court, with a power of law, applies to all Member States of the European Union.

Legally it is related to certain chapters of the 2001/83/EC European Community Council Directive, that in turn had become incorporated in national laws of all Member States of European Union, as mandated by Maastricht Treaty.

BCRO method of preparation of animal fetal precursor cell transplants is in full compliance

  • with the decision of the German Supreme Court in case of 1 BvR420/97,

  • with EU Directives, as well as

  • national laws of all Member States of European Union.

Rabbit fetuses (and newborns) are the animal source for the preparation of fetal cell transplants by BCRO method, as has been the case for the past 20 years.

Nowadays, when everyone panics about the 'Mad Cow Disease', it is important to stress that according to the world’s medical literature (and confirmed by the World Health Organization), no transmission of any viral disease has been known to occur from rabbit to man.

The natural barrier that has always existed in 'Nature' has been largely preventing transmission of infections between species. The more distant the species are, the stronger this barrier has been; and this is the case between rabbit and man.

  • Coming from a closed colony in existence for nearly 40 years,

  • with documented lineages,

  • having been bred and raised in captivity with a minimal exposure to vectors of infectious agents,


the rabbit fetuses used for preparation of fetal precursor cell transplants are and have been remarkably free of any disease.

Besides that, rabbit is the sole laboratory animal, in which no retroviruses have been identified yet, despite the fact that they should be present in all mammals.

It was
stated by USSR Ministry of Health in its regulations issued already in 1984, that no immunosuppression is necessary, when the cell transplants are prepared by the recommended method. Ample additional clinical evidence since then has further proven no clinically detectable immunogenicity after an implantation of BCRO fetal cell transplants.

No genetic manipulations are used in the preparation of fetal precursor cell transplants by BCRO method.



Fetal cell transplantation (FCT) is a surgical procedure in which an implantation of “cells containing live tissue fragments”, or cell clusters, of all organs and tissues, of human (allo-, or auto-) or animal (xeno-) origin, from fetal, neonatal or juvenile stage of life, is carried out as therapy of diseases of humans and animals (but not from embryonic stage of life).

Cell transplantation has been used successfully for 90+ years as treatment of many diseases for which modern medicine has had no therapy, or in which 'state-of-art' therapies stopped being effective. It is not a ’wonder drug’, or transplantation of some ’Mother-of-all-Cell’, i.e. universal stem cell, that cures everything!

It has been the only known treatment for clinical situations when a repair or healing of any mal- (or non-) functioning cell type, of any tissue(s) and organ(s), damaged by disease, injury, or abnormal growth & development, has been necessary to save life of the patient or avoid serious disability.

It is accomplished primarily by direct stimulation of regeneration of the patient’s own mal- (or non-) functioning cells of any damaged tissue(s) or organ(s), by transplantation of new cells, to replace the function of those destroyed in the patient’s body, already dead and replaced by scar tissue .

Without transplanted cells we, or any other member of animal kingdom, cannot regenerate any cell type our body is made of, and death becomes inevitable.

Without stem cells there is no life for any multi-cellular member of animal kingdom, e.g. mammals, Homo Sapiens.

The organisms of Homo sapiens and all mammals are built from the same ~200 to 220 cell types.

Fetal cell transplantation is the only known therapy today to accomplish direct stimulation of regeneration of the damaged cells of all tissues and organs by implanted cell transplants.

Cell xeno-transplantation in over 5 million patients during the period of 90+ years has not caused a single fatality, while there have been fatalities after human embryonic cell transplantation (only).

Peer-reviewed medical journals and media reports have been failing to state that

A/ the fact that embryonic stem cells are unusable for an actual patient treatment due to their oncogenicity has been known for nine decades;

B/ implantation of fetal precursor (or progenitor) cells, several generations older than embryonic stem cells, have been used as a treatment for 90+ years;

C/ fetal precursor cells of animal fetal origin are equally effective, and safer, for the cell transplantation treatment, and thereby all troubles with human embryonic stem and fetal cells can be avoided, i.e. moral, ethical, religious, etc.;

D/ therapeutic use of cell transplants of animal fetal origin in several millions of patients over the last 80+ years has accumulated sufficient data to prove, that cell transplantation is not dangerous to an individual patient or to a mankind.

Let’s analyze the above four issues.

A/ The fact that embryonic stem cells are unusable for an actual patient treatment due to their oncogenicity has been known for nine decades.

Embryonic stem cells have unique capability to renew themselves, i.e. proliferate, and are pluri-potent, i.e. they have the potential to differentiate into any and all specialized cells of the body, with characteristic shape, and function. They remain in an undifferentiated state, uncommitted, until they get a signal to develop into one of specialized cell type of the body.

But, embryonic stem cells apparently do not exist for any prolonged period of time in real life, i.e. in a living embryo, only in the laboratory dish.

The current optimism about embryonic stem cells is based on theoretical expectation of:

1/ their enormous ability to proliferate that makes them suitable for a factory level manufacturing of cells for therapeutic use. The unlimited potential of embryonic cells to proliferate sounds wonderful, but only until one does not recall that in cancer growth likewise one kind of cell stopped responding to the commands of the patient’s body, became independent, and became a ‘cell factory’.

2/ their capability to be manipulated into differentiation into any desired cell type to be used for cell transplantation treatment of patients. Manipulation of embryonic cells into differentiation, whereby precursors / progenitors of any and all specialized cell types of the body are created in a laboratory dish, is a wonderful idea, but also a formidable task, currently without a solution.

B/ Implantation of fetal precursor cells, several generations older than embryonic stem cells, have been used as a treatment for 90+ years.

The precursor cells used for implantation/transplantation are taken from fetus, at the stage of life, when organogenesis is already in progress. Such fetal cells are no longer pluri-potential and are committed to follow a predetermined path of differentiation along one lineage only,(in other words such cells are directed to produce cells that are specific for the kind of tissue, where these cells normally reside). They do follow the body commands.

They retain the ability to proliferate without pre-determined differentiation for a long time, i.e. they are capable of long term self-renewal. This is because in fetal body the undifferentiated stem cells live in a millieu of various differentiated cells, and there is a lot of interaction between them, which is not the case when undifferentiated stem cells grow in tissue culture.

The fetal precursor cells cannot create in a laboratory conditions a three-dimensional body, or an organ, or even a tissue, so the question arises whether these cells grown in a laboratory dish are indeed the same precursor cells that can be obtained from a fetus, where they have developed in a natural way, and where they created three-dimensional tissues and organs.

It appears more physiological to take precursor cells for transplantation from their natural environment in the fetal body, that means taking them together with other cells of the same ‘family’ in a cell-to-cell contact with each other, including cells of various generations of the same ‘family’, and then grow them in a primary tissue culture in order to have sufficient time for observation and safety tests, as well as for minimizing their immunogenicity, so that they can be implanted without immunosuppression.

The kind of environment, in which such cells are growing, i.e. either in tissue culture or in live human or animal body, makes a lot of difference when it comes to the direction of cell differentiation.

Heavily promoted use of cell lines for preparation of stem cell transplants is a fabrication of scientific facts by peer reviewed medical journals and media. Cell transplants prepared from cell lines have never been used in the clinical practice for patient treatment. It has been a ‘res ipsa loquitur’ for practicing cell transplantologists in Europe, that cell transplants prepared from cell lines are not therapeutically effective.

The definition talks about an implantation of tissue fragments, or cell clusters, not of dispersed cells. Cell line means culturing of dispersed cells. While the growth of cells in an organ/ tissue culture is influenced by a variety of interrelationships between cells, such interactions are lacking in the cell culture of dispersed cells. Due to that the growth of dispersed cells in cell culture is difficult to impossible.

Culturing of dispersed embryonic stem cells growing outside their natural environment is possible only on the cell matrices, currently known as ‘feeder layer’ of cells. The only other way is by culturing cells in their natural environment, inside of a living organism.

In cell line of any cell type as a result of living in artificial conditions of continuous cell culture, the cells are almost always abnormal. They are heteroploid, i.e. with an abnormal chromosome count, and due to the influence of selection so markedly changed, that they often cannot be recognized as derived from their tissue (or organ) of origin.

In cell lines sex chromatin disappears, cell division runs without any controls, there is a decreased production of acids released into the culture medium, cell membranes of daughter cells are incomplete, there is a lack of histo-typical differentiation.

BCRO method of preparation of cell transplants is based on the primary organ culture of tissue fragments, or cell clusters, and not on the primary cell culture of dispersed cells.

It has been proven beyond doubt, that cells in the tissue fragments communicate via contact, via soluble factors, and also via their electromagnetic fields. All such communications are missing in the cell culture of dispersed cells.

Primary organ culture, as used in the BCRO method of preparation of cell transplants, has a limited lifespan, determined by the lifespan of the tissue source of the culture, or of the donor. In primary organ cultures the cells maintain diploid set of chromosomes, typical for the normal somatic cells of the animal source of organ culture. They do not differ from the cells of the original organ or tissue planted on the organ culture neither structurally, nor biochemically. These cells grow in practically the same functional environment, as when they were a part of an organism from which they were taken.

Because of likelihood of oncogenicity, scientists and clinical experts in the field of fetal cell transplantation doubt that embryonic stem cell transplantation, human or animal, could ever be of any value in the treatment of human diseases.

But even if it would be, there would be serious questions about what is really helping the patient: human embryonic stem cells or the feeder mouse cells, without which the human embryonic stem cells cannot survive in a laboratory dish.

Is it just feeding or is it in reality a co-culture of human embryonic stem cells and mouse feeder cells? What is the outcome of such co-culturing is a question that needs an answer.

In 2004, human embryonic stem cell transplants were classified by CBER of U.S. FDA as ‘stem cell xeno-transplants’, because they cannot be grown in a laboratory dish without a feeder layer of mouse cells, and thereby they were placed under U.S. FDA regulation “PHS Guidelines on Infectious Disease Issues in Xenotransplantation”of January 19, 2001.

Another important issue is the comparison of the outcome of co-culture of feeder cells and embryonic stem cells in a Petri dish in laboratory conditions with the effect of implanted cells of animal fetal origin ’in situ’, when a ’co-culture’ takes place in the damaged organ of the human recipient / patient.

C/ Fetal precursor cells of animal fetal origin are equally effective, and safer, for the fetal cell transplantation treatment, and thereby all troubles with human embryonic stem and fetal cells can be avoided, i.e. moral, ethical, religious, etc.;

Res ipsa loquitur’ (‘matters speak for themselves’): there is no real difference between cell (or tissue) xeno-transplantation and allo-transplantation in clinical effectiveness: it was recognized by P. Niehans already in 30-ies of the last century and by all scientific leaders of German cell therapy in 50-ies.

For that reason there was no concern about inability to use human embryonic stem and fetal cells due to the prevailing ethical, moral, and religious, attitudes in western European countries.

When you place side-by-side human and animal embryonic stem cells, or human and animal precursor fetal cells of the same type, you find out that they look alike, and even most of the available cell-surface markers are the same. The only way to tell the cells of one species from another is by their karyotype, the number and shape of chromosomes, (temporary structures created from the genetic material of each cell during one short phase of cell division).

There is only one difference between Homo sapiens and the rest of mammals: the frontal lobe of the brain. The rest of the body of all members of animal kingdom, including man, is the same on cytological level.

Human cell transplantation, i.e. allo-transplantation, is not, and will not, be better than, or superior to, cell xeno-transplantation as the therapeutic tool in human medicine, until the quality of cell allo-transplants matches that of cell xeno-transplants!

That would happen only if human beings would be kept in closed colonies, and euthanasia would be permitted in the preparation of human fetal cell transplants.

The main point is a much better quality of the animal (in our case rabbit) source of cell transplants. While the animal (rabbit) material could be obtained always (!) fresh, i.e. cells are 100% live when planted onto the tissue culture medium, the same could hardly ever be stated about human fetal material, where for obvious reasons there is always a delay between the time of death and the dissection of human fetal cadaver, so that the viability of cells at the time of their implantation into the patient’s body or planting onto the tissue culture medium, is often in doubt.

Preparation of fetal cell xeno-transplants begins immediately after death of animal fetus, while preparation of fetal cell allo-transplants must await natural delivery of human fetus, dead for many hours by then.

Let’s review well established scientific data that have explained reasons why cell xeno-transplants can be used instead of cell allo-transplants with a ’state-of-art’ safety:

1/ It has been known since 19th century, and the entire modern cell biology is based on the fact, that all eukaryotic cells in Nature are built and function according to the same laws. In clinical practice of fetal cell transplantation we have been dealing with eukaryotic cells (of mammals) only.

2/ Main cells of the same organ or tissue are the same in Nature, (or nearly the same), regardless of the species of origin, i.e. corresponding cells of the identical organ of different animal species (including man) are biologically similar. We could make a similar statement about any of approximately 200 – 220 types of cells of human or animal body.

This scientific ‘principle of organospecificity’, described in German and Soviet/Russian literature decades ago, is still an unknown term in anglophone medical journals.


There are no antigenic differences between the corresponding cells of the identical organ of different animal species, including man. This is another proof of ‘organospecificity’.

3/ All biological systems in Nature are composed of the same types of molecules. Great majority of proteins from different organisms, including man, is similar over the entire amino acid sequence, i.e. they are homologous of each other and in general carry out similar functions. The homologous proteins evolved over billions of years from a common ancestor, and logically established a ‘principle of homology’.

4/ Basic law of molecular biology, whereby DNA directs the synthesis of RNA, that in turn controls the assembly of proteins, applies to all living beings. Genetic encoding is the same in most known organisms. ’Families’ of similar genes encode proteins with similar functions.

In cell transplantation it makes minimal difference whether one is dealing with xeno-transplantation or allo-transplantation when it comes to science. But there is an enormous difference in medical practice, since with cell xeno-transplantation we can treat already today hundreds of thousands of patients, suffering from those diseases, that cannot be cured or treated by any other therapy. Cell xeno-transplants can be prepared for nearly limitless number of patients, even if individually prepared for each named patient, and ultimately at low cost. While there has always been a shortage of human fetal cells and tissues for transplantation, the same is not true for the cells and tissues of animal fetal origin. It has been, and will be, hard to develop cell transplantation as a therapeutic method if there is enough therapeutic material for treatment of a few patients only: this situation has been slowing the progress for many years.

D/ Therapeutic use of cell transplants of animal fetal origin in several millions of patients over the last 90+ years has accumulated sufficient data to prove that cell xeno-transplantation is not dangerous to an individual patient or to a mankind. Cell xeno-transplantation has not caused a single fatality in ~5 million patients over 90+ years, or in any way jeopardized the future of mankind. Most researchers believe that xeno-transplantation is exceedingly unlikely to lead to the generation of new pathogens, providing that no laboratory ‘hokus-pokus’ is used in defiance of laws of Nature.

The above is particularly true if animal source of cell xeno-transplants is a domestic or laboratory animal from closed colony as required by U.S. FDA regulation ‘PHS Guidelines on Infectious Disease Issues in Xenotransplantation’ of January 19, 2001 (Federal Register, Volume 66, Number 19, pages 8120 – 1). The key premise of the U.S. PHS regulations is to increase the safety of FCT for the benefit of the recipient patient, but also to minimize, or eliminate, any medico-legal exposure for the treating physician as well as the laboratory individually preparing fetal cell transplants for each named patient.

All BCRO fetal cell xeno-transplants are prepared by a primary organ culture, whereby there is an ample time for close observation, to ascertain that each organ culture is free of any disease or abnormality.

The most important feature of BCRO’s procedure of preparation of fetal cell xeno-transplants is an attainment of an almost complete immunological tolerance of fetal cell xeno-transplants by the recipient, as a result of which there is no need for an immunosuppression whatsoever, since clinically detectable reactions of patient’s immune system to FCT have not been observed or measured.

With BCRO’s method of preparation of fetal cell xeno-transplants the ideal organ culture growth conditions are created for one cell type of a tissue or an organ, necessary for therapeutic effect, unfavorable at the same time for all other cell types of the same tissue or organ, which are useless for treatment and create an ‘antigenic overload’, that triggers immune reactions (which otherwise would not occur). At the same time the antigenicity of fetal cell xeno-transplants is cut to a minimum by the primary organ culture, too.

BCRO’s method is equally applicable to the preparation of fetal precursor cell allo- or xeno-transplants.

Res ipsa loquitur:

1/ The natural barrier has been known to prevent transmission of infections between species to a substantial degree: that applies for example to domestic rabbit and wild hare, unrecognizable from each other.

2/ More distant the species are, the stronger has been this natural barrier. It has been 100% true between rabbit and man. To-date there have been no reports of rabbit-to-man transmission of any virus.

3/ No retrovirus has been found in rabbits to-date!

4/ Coming from a certified closed colony, the fetal and newborn rabbits have been found remarkably free of any disease.

The BCRO procedure of preparation of fetal cell xeno-transplants by a primary organ culture procedure, the final step to assure a nearly complete loss of immunogenicity, permits implantation of fetal cell xeno-transplant directly into arteries / veins, into cerebrospinal fluid, into various parts of parenchyma of any organ, including brain (although seldom necessary), into all body cavities, etc., without immunosuppression(!).

One of the key reasons for the high therapeutic success rate of FCT by BCRO method is the fact that no immunosuppression has to be used with implantation.

Immunosuppression has been one of the main reasons, why the success rate of cell transplantation has been so low in those lands, where the use of immunosuppression has been considered mandatory. Besides toxicity to the patients, it is detrimental to fetal cell transplants, because these very young cells are enormously sensitive to any toxin, i.e. all immuno-suppressants.

Until we learn what life is and can explain various aspects of the function of the living body, we have to be satisfied with the fact that implantation of fetal cell transplants prepared by the ‘state-of-art’ method does not cause clinically apparent immune reactions.

There are many published medical reports on hundreds of patients showing that changes of laboratory parameters of the immune system function before and fetal cell transplantation are minimal and statistically not significant, providing fetal cell transplants are prepared ‘state-of-art’.

In 1984 the Regulations of USSR Ministry of Health stated, that immunosuppression is not necessary for cell transplantation if fetal cell (allo- or xeno-) transplants are prepared by a certain method of primary tissue culture.



Clinical practice of fetal precursor cell transplantation:

1/ Cell transplantation is a vastly different approach to medical treatment and cannot be immediately understood by the mind accustomed to deal with (chemical) drug therapy. The therapeutic effect of drugs of chemical origin is not as broad as those of any of the ~ 200 – 220 known types of cells that could be transplanted into a diseased body.

Every diseased organ of the body can be treated by fetal cell transplantation, it is just a matter of finding out what type of cells to use for transplantation: that requires knowledge, and clinical sense, since diagnostic possibilities are still inadequate. Diagnostic tools are standard, but the physician/clinician taking care of a patient must evaluate his findings as patho-physiologist.

Every disease means that more principal cells of a diseased organ dies than are replaced by cell division. When there are too few main cells of any organ of human body left, that organ stops its function , and if such organ cannot be replaced by organ transplant, the human body will stop functioning too, it all depends if it is an organ without which we cannot live, e.g. heart, brain, for example.

2/ Prescribed fetal cells for a specific patient do not have to be implanted into damaged organ or tissue, i.e. liver stem cells into liver, but into much more accessible superficial tissues, as for example under the aponeurosis of the rectus abdominis muscle, or deeply subcutaneously in the gluteal area, since transplanted fetal cells find their way into the damaged organ or tissue, as if ‘attracted’ by it. This is known as ‘homing’.

Damaged cells of a diseased organ or tissue emit signals to the implanted fetal cells “SOS, we need help”, and within 48 – 72 hours the implanted clusters of cells of a specific (‘prescribed’) organ or tissue of a donor (i.e. fetal cell transplants) disappear from the host implantation site, whereupon an average of 75% of implanted cells incorporate - within 5 to 7 days - in the identical organ & tissue of the host, provided that such organ or tissue is damaged.

The more extensive damage of target organ or tissue, the higher proportion of the transplanted cells will ‘home’ into that same organ or tissue.

If fetal cell transplant implanted into a patient is the same as that of diseased organ or tissue, then transplanted cells incorporate into the diseased organ or tissue, with therapeutic effect. If fetal cell transplant implanted into a patient is the same as that of normal (‘non-diseased’) organ or tissue, then transplanted cells disperse throughout the organism of a patient, without any therapeutic effect. (Halsted principle, 1909)

3/ Since it is rare that only an individual organ is malfunctioning, i.e. usually the whole organ systems are diseased, it is necessary to treat all ailing organs by corresponding cell transplants.

The list of cell transplants necessary for treatment of each patient has to be individually selected in terms of particular cell types, dosage and preferred route of implantation. Such list is based on the pathophysiologic diagnosis (-es) of the patient, i.e. the physician must pay attention to the abnormalities of each & all organs and organ systems of the patient and based on that, a pathophysiologic diagnosis (-es) for the patient.

Timing of fetal cell transplantation is extremely important: the sooner after the onset of disease it is carried out, the better will be the therapeutic results.

Fetal cell transplantation is a surgical procedure indeed, and not a therapy by mass produced drugs. All surgical operations are ‘individualized therapeutic procedures’. Double blind studies have never been used for evaluation of results of surgical procedures. Even fetal cell xeno-transplants are not, and will not, become ‘mass-produced therapeutics’.

INDICATIONS:

1/ Diabetes Mellitus, types 1 and mixed 1/2, also type 2 in non-obese patients,when complications have already developed, such as:

a. Diabetic Retinopathy;
b. Diabetic Nephropathy;
c. Diabetic Polyneuropathy;
d. Diabetic Lower Extremity Arterial Disease; as well as
- Brittle Diabetes Mellitus in children; and
- Diabetes Mellitus in pregnancy, or diabetes mellitus as a cause of female infertility and of habitual pregnancy loss;

2/ Other hormone deficiency disorders, where hormone replacement therapy could not re-establish a normal hormonal balance;

3/ Early menopause, and some other serious gynecological diseases, where state-of-art treatment has failed;

4/ Male and female infertility, where usual treatment has failed;

5/ Immune deficiency disorders, such as chronic weakness syndrome, AIDS, cancer, etc., as well as autoimmune illnesses;

6/ Aging disease, including menopause, impotence, depression, etc.;

7/ Parkinson’s and other degenerative diseases of CNS, stroke due to blood clot, injuries of central nervous system, acute or old, etc.;

8/ Degenerative diseases of cardiovascular system, liver, gastrointestinal tract, and other organ systems;

9/ Many genetic and chromosomal diseases of children, such as Down syndrome, as well as failure to thrive, mental retardation, frequent illnesses, autism, etc., due to various prenatal, natal and postnatal causes;

10/ Others: burns, reconstructive surgery.



Contra-indications:

Absolute: terminal stages of disease(s), severe acute exhaustion.

Temporary: acute infection, untreated chronic (focal) infection, uncontrollable severe hypertension, uncontrollable severe allergic status.



book

Textbook on Stem Cell Transplantation by E. Michael Molnar, M.D. published in February 2006 in Washington, D.C., U.S.A.

 

 

 

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Updated: February 2019