Masthead7

Manufacturing

Our method of manufacturing of individually for each patient prepared cell transplants 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), that 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 this type of treatment, in medical practice in Germany since early 50-ies, had continued to be permitted.

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.

(You can request from us the entire 2001/83/EC Directive)

Our preparation of 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.

Our staff has been involved in the research and clinical applications of the cell transplantation for over 32 years in thousands of patients and we have been offering for sale a full assortment of cell transplants from all organs and tissues of animal fetal origin (from rabbits) since 1998.

BCRO’s manufacturing laboratory is set-up, equipped and staffed in compliance with the regulations of PHS, and Directives of the European Union Council. Good Manufacturing Practice (GMP) standards are strictly adhered to in all aspects of the work of our laboratories. Preparation of cell transplants is carried out by our staff of D.V.M.’s and Ph.D.’s, under direct supervision of authors of our ‘Know How’.

Rabbit fetuses (and newborns) are the animal source for the preparation of cell transplants by our exclusive 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.

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 (and newborns) used by us 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 regulatory agency already in 1984, that no immunosuppression is necessary if the cell transplants are prepared by our unique method.

Ample additional clinical evidence since then has further proven no clinically detectable immunogenicity after an implantation of our fetal precursor cell transplants.

No genetic manipulations are used in the preparation of cell transplants by our method.

BCRO fetal precursor cell transplants that you will receive from us are live cells prepared especially for you! It takes a minimum of 17 days from the moment that we have received your payment, before you will have BCRO fetal precursor cell transplants in your hands. If this appears too long, allow us to remind you that we have to synchronize pregnancies of several rabbit females for preparation of cell transplants for one client. Since fetal and newborn rabbits are from a closed colony, with a finite number of females, this requires a day or so to coordinate.

The preparation of cell transplants by primary tissue culture takes 11 days, and their delivery to you another 1 – 2 days. After their release from the factory, your fetal precursor cell transplants are immediately shipped to you via courier.

Beware that once the cycle of the preparation of your fetal precursor cell transplants has begun, ‘everything is in the hands of Nature’, and we cannot abort it. Your fetal precursor cell transplants can be used only by you.