Our manufacturing of 'individualised' prepared Stem Cell Therapy for each patient certainly incorporates all pertinent requirements of ”PHS Guidelines on Infectious Disease Issues in Xenotransplantation” (click here for pdf format) of January 19, 2001 (Federal Register, Volume 66, Number 19, pages 8120 – 1). This 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 here for pdf format) the German Supreme Court ('Bundesverfassungsgericht') re-affirmed that this type of treatment, in medical practice in Germany since early 50s, had continued to be permitted, whereby Germany had re-established its leadership in this field. 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 download the entire 2001/83/EC Directive , but the size of 380 kB may take some time).
Our manufacturing of stem cell therapy is in full compliance with :
- the decision of the German Supreme Court in case of 1 BvR420/97
- EC Directives
Our staff has been involved in the research and clinical applications of the stem cell therapy for over 25 years in thousands of patients and we have been using SCT of animal origin since 1998. FCTI's manufacturing laboratory is set-up, equipped and staffed in compliance with the regulations of PHS, Directives of the European Union Council. Good Manufacturing Practice (GMP) standards are strictly adhered in all aspects of the work of our laboratories.
The safety aspects include :
- a closed colony in existence for over 30 years since 1973
- documented lineages
- 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, rabbits are 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 reported in official medical literature in 1984, that no immunosuppression is necessary if the stem 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 stem cell transplants. No genetic manipulations are used in the preparation of stem cell transplants by our method.
Stem cell transplants that you will receive from us are live cells prepared especially for you. FCTI Proprietary Primary Cell Tissue Culturing for individualised prescription commences from 14-17 days of preparation. We have to synchronize pregnancies of several rabbit females for preparation of stem 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 stem cell transplants by primary tissue culture takes 11 days, and their delivery to you another 1 - 2 days.