Manufacture Of Our Individually For Each Patient Prepared BCRO Fetal Precursor Cell Transplants
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) (click on the above link if you want to read a complete text of this FDA regulation),
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 (click on this link if you would like to read a complete text of the Court decision in German), 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 (click on this link if you want to read to read selected chapters related to cell transplantation) 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 download the entire 2001/83/EC Directive)
Our preparation of cell transplants is in full compliance
Our staff has been involved in the research and clinical applications of fetal 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.
BCROs 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 fetal 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 worlds 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.
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.
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 fetal 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 currier.
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.
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|Copyright Stem Cell Transplantation Ltd.|
|Updated: December 2018|