Results of First FDA-Approved Cellular TherapyCarticel was used in patients who had defects in the joint cartilage of the knee. The defect was of the femoral condyle, the rounded end of the thighbone that forms the top half of the knee joint. All patients had a poor response to surgical repair before receiving Carticel.
The FDA reported a 3.8 percent adverse event (AE) rate. AEs included graft failure, delamination, tissue overgrowth, and infection. Delamination is the separation of the outer coating of the graft or splitting of the graft into separate layers.
The FDA says these problems are fairly common and are not unique to Carticel. Safety of this product will continue to be monitored and reported to the public. Only the company making Carticel must report problems and only those AEs that occur within the first 15 days.
Researchers studying Carticel say problems can occur from day one up to six years later. The overall AE rate may be really more than 3.8 percent if all cases are reported.
Tina DiMarcantonio. FDA Reports on Chondrocyte Implant's Adverse Events. In Orthopedics Today. April 2006. Vo. 26. No. 4. Pp. 59.
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