An increasing number of reports about the clinical use of autologous cells manipulated in vivo and implanted into the same patient prompted the U.S. Food and Drug Administration (FDA) to hold a public hearing in November to review the public health impact of these products and possible regulatory approaches.
The FDA's approach to the regulation of human somatic cells and gene therapy calls for these therapies to undergo the standard IND and Establishment and Product Licensing Application process applicable to biologicals.
However, in a statement announcing the public hearing the FDA said it "recognizes the potential for evolving technologies and scientific advances to require modifications to its approach."
Among the techniques discussed was the removal and reimplantation of a patient's own cartilage cells to fill a cartilage defect in the knee. The process was developed in Sweden and is being offered to patients in the United States as the Carticel service by Genzyme Tissue Repair, a division of Genzyme Corp.
As of October 25, Genzyme had trained 78 orthopaedic surgeons to perform the treatment. The procedure had been done on 32 patients. The company had a waiting list of 288 orthopaedists who wanted to participate in the two-day training session.
Genzyme Tissue Repair started the service last March. The FDA raised questions about which unit within the agency had jurisdiction over the process. Genzyme Tissue Repair filed a petition with the FDA to resolve the issue and suspended the procedures. In July, the FDA said it did not intend to regulate the Carticel service at that time and the service was resumed.