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U.S. Department of Health and Human Services

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Carticel (autologous cultured chondrocytes) Dear Healthcare Professional Letter Mar 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Genzyme Tissue Repair. Contact the company for a copy of any referenced enclosures.

March 10, 2000

IMPORTANT Prescribing Information

Dear Doctor:

We are writing to inform you of a change in the product labeling for Carticel® (autologous cultured chondrocytes). This change narrows the indications for Carticel to second line therapy for the repair of cartilage defects of the femoral condyle. The new indication reads as follows:

"Carticel is indicated for the repair of symptomatic, cartilaginous defects of the femoral condyle (medial, lateral, trochlear), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure."

We have enclosed a copy of the revised package insert for your information.

In August of 1997, FDA granted accelerated approval for Carticel for the repair of symptomatic, cartilaginous defects of the femoral condyle, including both primary and secondary repairs. As a condition of this approval, GTR (Genzyme Tissue Repair) agreed to conduct two studies, including a multi-center, randomized controlled trial in 300 patients comparing Carticel to other primary cartilage repair techniques, to confirm the benefits of Carticel in this setting.

Because Carticel is the first cell-based therapy for orthopedic use approved by the FDA, a number of unique regulatory and clinical research issues arose during its development and approval. GTR and our investigators were not able to enroll adequate numbers of patients in either of the planned studies. As studies could not be performed to confirm benefits of Carticel in first line use, GTR requested to change the indications as described. GTR will conduct studies to confirm the benefits of Carticel in patients who have had an inadequate response to a previous arthroscopic or other surgical repair procedure. In these studies, patients will have long-term outcomes of Carticel therapy assessed and compared to the response to their previous surgical repair procedure. The FDA is currently reviewing the proposal for these studies.

If you have any questions or comments regarding the revised label, our planned studies, or you would like other additional information, please contact the Physician and Patient Services Department at 800-453-6948.

Sincerely,

David W. Levine, M.D., M.P.H.
Medical Director, Bio-Orthopedics
Genzyme Tissue Repair

Enclosure


Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139-4136
Phone No. 617-494-8484
Fax: 617-494-6561