BIO-CELLULAR RESEARCH ORGANIZATION
 BCRO Fetal Precursor CELL TRANSPLANTATION

 

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ABOUT US

Bio-Cellullar Research Organization ('BCRO') was founded in 1989, as a U.K. company (England and Wales). In January 1992 a company of the same name was registered in Ireland, and the U.K. company was closed down. 

In 2001, when a new U.S. administration of President Bush began to support stem cell transplantation, the company of the same name was registered in U.S., and the Irish company was closed down. It has always been a limited liability company.

In 2009 the company returned to Ireland, registered under the name Stem Cell Transplantation Ltd. (and the business name 'Bio-Cellular Research Organization').

BCRO was created to serve as a legal structure for an ongoing project of fetal precursor cell xeno-transplantation by a group of physicians-experts in this field from various western countries. 

BCRO has brought this old therapy up to the 'state-of-art' level, in particular by developing the preparation of cell xeno-transplants, with worldwide delivery.

From 1976 until 1989 this project was carried out under various California corporations and non-profit foundations.

BCRO has become the leader of the fetal precursor cell xeno-transplantation field, since

  1. by our unique technology of tissue culture we had overcome the problem of adverse immunological reactions toward ’s, whereby their therapeutic use does not require immunosuppression,
  1. we lowered the risk of transfer of xeno-zoonoses (infections transferred from animals to humans) down to zero by fulfilling pertinent requirements of ”PHS Guidelines on Infectious Disease Issues in Xenotransplantation” of January 19, 2001 (Federal Register, Volume 66, Number 19, pages 8120 – 1), issued initially as a ”Draft” on September 23, 1996 (available from Federal Register under 61FR49920.

When we began 33 years ago faced serious legal obstacles everywhere. 

In U.S. it all changed when 61FR49920 was issued. 

In Germany, 'Bundesverfasssungsgericht', the highest level of German Supreme Court, on February 16, 2000, by its decision in the case number 1 BvR 420/97, re-affirmed the original approval of therapeutic use of cell xeno-transplantation from early fifties. 

This German decision had serious implication for the remainder of the European Community as well. Under the European Community Council Directives, all Member States of EC are obliged to accept laws and regulations of other member States of European Community dealing with medical therapeutics for human use, and that includes fetal precursor cell xeno-transplantation.

Our mission has been to:

  1. manufacture the 'state-of-art' BCRO fetal precursor cell xeno-transplants by primary tissue culture in accordance with our proprietary procedure and related know-how, to be used for treatment that has saved lives and minimized the disability of patients, particularly those declared beyond help by modern medicine,
  2. deliver our BCRO cell transplants worldwide,
  3. educate and consult physicians and patients in the clinical aspects of cell transplantation.

 cell transplantation has been our business for 30+ years now: we researched it, and developed it commercially from the ground. 

In May 1998 we prepared our first series of cell xeno-transplants for three groups of dozen patients each. 

All applicable regulations of PHS, and EU Directives, were incorporated in our preparatory technology, and that was of enormous importance in order to attain the heretofore unknown 'state-of-art' level of safety of fetal precursor cell xeno-transplantation.

After the initial proposal submitted in December 1996, and preliminary discussion with U.S. FDA at their Headquarters in April 1997, BCRO filed in February 1999 four IND ('Investigational New Drug') applications for U.S. clinical trials of the treatment of

  • diabetic retinopathy, 
  • diabetic nephropathy, 
  • diabetic polyneuropathy, and 
  • diabetic lower extremity arterial disease, 

with fetal precursor cell xeno-transplantation, by our BCRO method. 

Our selected bibliography attached to these IND applications includes many key publications about clinical results of the treatment of diabetic complications with cell xeno-transplants not found on MEDLINE.

Our IND applications with U.S. FDA were partially based on the fact that in 1993 and 1995 BCRO treated in California 56 U.S. patients with complications of insulin-dependent diabetes mellitus in four clinical trials, with success.

Although we think that Sandoz (now a part of Novartis) was responsible for convincing U.S.FDA to change its attitude toward xeno-transplantation, we helped as well, by making headlines in 1993 in U.S. media, which - besides other ugly and destructive publicity - announced our clinical trials of the treatment of U.S. patients with complications of diabetes mellitus by transplantation of 'rabbit cells'.

From a regulatory viewpoint BCRO fetal precursor cell transplant represents a very unique 'product', which really is not a 'product'at all, because it does not fulfill the legal definition of a medicinal product(!). U.S.FDA’s regulations label live cell xeno-transplants as 'products', while under German law they are classified neither as 'drugs' nor as 'medications' ('arzneimittel' in German), because

  • they are individually prepared for each patient,
  • they are for one time use only, by implantion on a pre-determined date,
  • the implantation is carried out by a physician who wrote a prescription for the cell transplants used,
  • cell transplants have no 'shelf-life', and
  • they are not distributed through the usual channels.

The European Community Council’s Directives are in harmony with this German legal concept, and thus European Community Member States do not classify fetal precursor cell xeno-transplants as 'products' either.

Before we agree to prepare a group of cell transplants for an individual patient ('batch') we have to 

  • receive a prescription from a physician known to us as possessing an expertise in cell transplantation, or 
  • if a physician cannot write such prescription without a consultation with us then we have to get a medical summary of that patient, to be certain that the treatment by fetal precursor cell transplantation is indeed indicated. 

    In this case we inform the patient of our decision, and if positive, then patient’s physician writes a prescription for fetal precursor cell transplants to be prepared for his/her patient by our company. A date for implantation of cell transplants is set as for any elective surgery.

The manufacture of prescribed cell transplants for the given patient is so timed that they are released less than 48 hours before the implantation date. Immediately thereafter they are delivered to the ordering patient by a currier. 

There is no 'shelf-life' for BCRO cell transplants, i.e. no storage whatsoever. The label on our fetal precursor   cell transplants declares “expiration in 7 days, but an implantation within 48 hours of the ‘batch release time’ is strongly advised”.

In the absence of a specific laws dealing strictly with cell xeno-transplantation, such as exists in European Union, in some other European and Asian countries, and to a degree in the U.S., the regulatory situation in other countries is often unclear since BCRO fetal precursor cell transplants definitely do not fit under the laws on drugs and other mass produced therapeutics(!), but they may fall under the laws on organ and tissue transplantation, however.

In addition to its stem cell transplants BCRO developed and manufacture ultrafiltrates, transfer factors, dendritic cells and dendritic cell vaccines, for human therapy.

Our research team has worked on the development of bioprostehes and artificial organs based on our fetal precursor   cell transplants.
 
BCRO type of fetal precursor cell transplantation,  has been used successfully for 80+ years as treatment of many diseases
  • for which modern medicine has had no therapy (i.e. incurable), or
     
  • in which 'state-of-art' therapies stopped being effective (i.e. no longer treatable),

in documented over 5 millions of patients worldwide. Physicians can learn about it in a textbook by E. Michael Molnar, M.D.: Fetal Precursor Cell Transplantation, BCRO Fetal Precursor Cell Transplantation", published in 2014 by www.amazon.com
On the same web site the general readership can find out all about it in the book by the same author: “Treatment of Incurable and No Longer Treatable Diseases”, published in January 2015, as well as in his autobiography: “Diseases and Genocide are not Our Destiny”. You can buy it as 'free reader download for PC' as well as Kindle Book.

 

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Updated: March 2015