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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

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. 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 ‘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’ 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 a 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 cell therapy, 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 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 were disqualified by the European

experts with lifelong clinical experience. .

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 to

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 spread a lot of

information about stem cells and the launch of the project appeared imminent. Then came 9/11/2001 and with that a complete silence from the

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.

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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 just 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 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 the facts that follows 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 as 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.

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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. Reason?

They are exhausted of dealing with one continuous string of scandals.’ Subsequently several hospitals and clinics heavily promoting stem cell

transplantation in the West 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 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 supervise it. You just keep on preparing 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 this short web site. If you wish to study the issues in depth you may decide

to consult the textbook “Stem Cell Transplantation, a Textbook of Stem Cell Xeno-Transplantation” for physicians by E. Michael Molnar, M.D., published

in February 2006 in Washington, D.C., U.S.A., the sole such textbook in the world.

6/ If you decide to consult your own physician, make sure that you are asking a professional that actually knows something about stem 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.

8/ Further on in the summary of scientific facts you will learn that

‘fetal precursor stem 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 stem cells can be avoided’. Why safer? By U.S.

law all animals used for preparation of stem 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 stem cell transplants. Could human

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beings be kept under such observation before using their fetuses for the

preparation of human fetal precursor stem 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 stem 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 stem cell transplants one

must wait for the natural or induced birth of the second trimester fetuses, necessary for preparation of human fetal precursor stem 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 stem cells

cannot ever match that of animal fetal precursor stem cells.

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

9/ Beware that umbilical cord blood, or peripheral blood, contain only stem cells of hematopoietic and immune systems, as well as a very limited

quantity of stem cells of mesenchyme, rather than stem 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 stem cell transplants, or by peripheral blood stem 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 stem cell transplantation are

useful only for the treatment of diseases of hematopoietic and immune system.

BCRO clinical method of stem cell transplantation based on the German

school requires that the treatment be 'individualized' by 'tailoring' the

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combination of stem cell transplants to a pathophysiology of specific

disease(s) of a specific named patient 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 to physicians of many medical schools, governmental medical research institutes, hospitals of Apollo Group

Hospital Corporation, as well as to give BCRO SCT 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 him 18 months later he was in the pre-

terminal state. There was no way to continue to lie 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 type of stem 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 type of stem 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

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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.

Stem 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 stem 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 stem 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 a traumatic procedure of needle biopsy, with possible complications: liver, kidney, spleen, thyroid, while for others endoscopy,

laparoscopy, excisional biopsy of various magnitude, or larger invasive procedure, etc. 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

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wealthy after the sale of his patent to the pharmaceutical industry. He

became an owner of 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 a 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 stem 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 kind 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 SCT 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

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source for many different stem cells, including that of neurons, in a

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 stem cell transplantation

to see if it works, i.e. helps the patient.”

One can get very easily stem cells of all ~200 – 220 cell types human body

and bodies of all mammals are made off, 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

stem 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 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 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 make profit in cell transplantation. We 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 “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

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(Cyclosporin) and our method of 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

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 cell and

tissue 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 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 stem cell xeno-

transplants, with proofs of effectiveness obtained decades ago, and an enormous clinical experience accumulated.

You may get confused when terms ‘stem cell transplantation’ and ‘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 cell

transplantation. Experienced practitioners of cell transplantation recognized decades ago that cell transplants of various organs or tissues contain all

generations of the family of a certain cell type, including those of the precursor stem cells, i.e. they treated their patients by stem cell

transplantation for many years even though a term ‘stem cell transplantation’ was not coined yet.

BCRO method of stem 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 stem cell therapy immediately after the diagnosis was made as

time is of essence. Stem cell xenotransplants prepared by a BCRO method 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 journal and (stem) cell

transplantation. For example, type 1 diabetics must be treated by insulin alone until they develop complications; at that time stem cell transplantation

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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.

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 and fetal cells in medicine have been easily resolved by using stem cell transplantation of

animal fetal origin to help patients suffering from deadly incurable, or untreatable, diseases. Therapeutic use of (stem) 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’ (stem) cell transplants to-date.

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

incurable or no longer treatable diseases.

Summary of scientific facts:

Precursor stem 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 stem cell transplants can be obtained from animal

sources.

Xeno-transplantation means the transplantation of live cells, tissues, or

organs between the species, in our case from animals to humans, or reverse.

Allo-transplantation means a 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.

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BCRO method has been preparing stem cell transplants from rabbit fetuses.

Immunosuppression – to use it or not to use it with stem 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 stem 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 stem 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 stem 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 stem cell transplants, because these

are very young cells, enormously sensitive to any toxin, and immunosuppressants are indeed highly toxic!

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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 (stem) 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 stem 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

(stem) cell transplants by BCRO method, as has been the case for the past 14 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.

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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 animal fetal precursor stem 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 type of stem cell transplants.

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

(Stem) cell transplantation (SCT) is a surgical procedure in which an

implantation of stem 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, juvenile, or adult 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 80+ 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 such damaged tissue(s)

or organ(s) or by transplantation of new stem cells to replace the function of those destroyed in the patient’s body, already dead and replaced by scar

tissue .

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Without stem 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 multicellular 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.

(Stem) 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 stem cells.

Cell xeno-transplantation in over 5 million patients during the period of 80+ 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 eight decades;

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

for 80+ years;

C/ fetal precursor stem cells of animal fetal origin are equally effective, and

safer, for the (stem) cell transplantation treatment, and thereby all troubles with human embryonic and fetal stem cells can be avoided, i.e. moral,

ethical, religious, etc.;

D/ therapeutic use of (stem) cell transplants of animal fetal origin in several

millions of patients over the last 80+ years has accumulated sufficient data to prove that stem cell xeno-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 eight 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:

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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 (or progenitor) stem cells, several

generations older than embryonic stem cells, have been used as a treatment for 80+ years.

The precursor stem cells used for implantation/transplantation are taken

from fetus, at the stage of life when organogenesis is already in progress. Such precursor stem 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 stem 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 precursor stem 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 stem 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 stem 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 stem 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.

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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 stem 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 (stem) 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 (stem)

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.

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Because of oncogenicity scientists and clinical experts in the field of stem 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 stem cells of animal fetal origin are equally effective, and

safer, for the stem cell transplantation treatment, and thereby all troubles with human embryonic and fetal stem 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 embyonic and fetal stem 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 stem 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.

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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 stem cell allo-transplants matches

that of stem 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 stem cell xeno-transplants begins immediately after

death of animal fetus, while preparation of fetal stem 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 stem cell xeno-transplants can be used instead of stem 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 stem 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

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homologous proteins evolved over billions of years from a common ancestor,

and logically established a ‘principle of homology’.

4/ The 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 (stem) 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

(stem) 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. (Stem) 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 stem 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 stem cell transplants of animal fetal origin in several

millions of patients over the last 80+ years has accumulated sufficient data to prove that stem 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 80+ 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 SCT 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 stem cell transplants for each named patient.

All BCRO (stem) 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 (stem)

cell xeno-transplants is an attainment of an almost complete immunological tolerance of (stem) cell xeno-transplants by the recipient as a result of which

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there is no need for an immunosuppression whatsoever, since clinically

detectable reactions of patient’s immune system to SCT have not been observed or measured.

With BCRO’s method of preparation of (stem) 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 (stem) 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 stem 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/ The 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 (stem) cell xenotransplants by a

primary organ culture procedure, the final step to assure a nearly complete loss of immunogenicity, permits implantation of stem cell xenotransplant

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 SCT 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 stem cell transplants, because these very young cells are enormously sensitive to any toxin, i.e. all immunosuppressants.

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

stem cell transplants prepared by the ‘state-of-art’ method does not cause clinically apparent immune reactions.

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There are many published medical reports on hundreds of patients showing

that changes of laboratory parameters of the immune system function before and after stem cell transplantation are minimal and statistically not

significant, providing stem 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 stem cell (allo- or xeno-) transplants are prepared by a certain method of primary

tissue culture.

Clinical practice of fetal precursor stem 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 stem 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

pathophysiologist.

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 stem 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 stem 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 stem 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. stem 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 ‘home’ into that same organ or tissue.

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If stem cell transplant implanted into a patient is the same as that of

diseased organ or tissue, then transplanted cells incorporate in the diseased organ or tissue, with therapeutic effect. If stem 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 stem cell types, dosage, date 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 establish a pathophysiologic diagnosis (-es) for the patient.

Timing of stem cell transplantation is extremely important: the sooner after

the onset of disease it is carried out, the better will be the therapeutic results.

Stem 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 stem 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;

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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.

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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