STEM CELL PHARMA WARNED FOR CONDUCTING STUDIES WITHOUT APPROVED LICENSE
The FDA warned Stem Cell Pharma for implanting stem cells in test subjects without following any standard operating procedures (SOPs) and without an approved license.
An agency inspector investigated the firm July 6 to review the company's implantation of amnion tissue to treat a variety of illnesses. The company violated several regulations regarding the proper conduct of clinical studies and failed to follow proper procedures, according to the warning letter, sent Nov. 22 and posted recently to the FDA website.
At least one Stem Cell Pharma physician took human placentas from a local hospital to his office, processed the tissue and implanted them in at least 16 recruited subjects without any established procedures, the warning letter said.
According to the warning letter, the company did not establish or maintain SOPs for:
Obtaining the placentas from donors;
Donor eligibility screening;
Processing of placentas to obtain amnion tissue and cells;
Testing the placentas for contaminants;
Screening the subjects for suitability in accepting the tissue and cell implants;
Implantation procedures; or
Subject follow-up for adverse experiences after the implantation.
The warning letter can be viewed at www.fda.gov/cber/compl/stem112206.htm (http://www.fda.gov/cber/compl/stem112206.htm).