Since U.S. medical authorities frowned upon fetal cell xeno-transplantation for decades, and U.S. FDA actually banned cell therapy in 1956, it was a great surprise when U.S. FDA issued the ‘Draft of PHS Guidelines on Infectious Disease Issues in Xenotransplantation’ on September 23, 1996, (Federal Register FR 49920).
Interestingly, U.S. FDA invited in April 1996 Prof.Dr. Franz Schmid, the author’s teacher of zellentherapie since 1981 until his death in 1997, to the U.S. FDA Headquarters to lecture their leaders over 2-days’ about fetal cell transplantation (or zellentherapie).
It was just 5 monthsbefore the issuance of “Draft….” When Prof.Dt Schmid advised the author about it, it became immediately clear to him who is responsible for the exceptionally lucid wording of FR 49920.
Prof.Dr. Schmid became following the death of Prof.Dr. Paul Niehans the leadimg authority in the field of fetal cell xeno-transplantation in Germany, (and thereby in the world) , recognized by the German government by appointing him the Chairman of both Committes of the West German Bundes Gesundheit Amt (the same as U.S. FDA) supervising the field of zellentherapie in that country.
Unfortunately he did not convince U.S. FDA officials to recognize that around 5 million of patients was treated by cell therapy in Europe during a period of 65 years by then, and that an enormous clinical experience was acquired there.
FR 49920 then on January 19, 2001, became…