Carticel

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Subsequent Surgical Procedures

Review of the data from the Study of the Treatment of Articular Repair (STAR) and the Registry Based Study (RBS) [see Clinical Trials Experience] as well as the Carticel (autologous cultured chondrocytes for implantation) worldwide experience (adverse reactions solicited through the Cartilage Repair Registry (CRR) and spontaneous reports) as of November 21, 1997 showed that the occurrence of a subsequent surgical procedure, primarily arthroscopic, following Carticel (autologous cultured chondrocytes for implantation) implantation is common. In the STAR study, 49% of patients underwent a subsequent surgical procedure, irrespective of relationship to Carticel (autologous cultured chondrocytes for implantation) (6.2). Symptoms leading to arthroscopic intervention included catching, locking, clicking or pain. Patients who develop clinical signs of tissue hypertrophy, including catching or clicking, should be evaluated and arthroscopy may be indicated for treatment or further assessment.

Risk of Transmissible Infectious Diseases

The Carticel (autologous cultured chondrocytes for implantation) product is intended solely for autologous use. Patients undergoing the surgical procedures associated with Carticel (autologous cultured chondrocytes for implantation) are not routinely tested for transmissible infectious diseases. Therefore, the cartilage biopsy and the Carticel (autologous cultured chondrocytes for implantation) product may carry the risk of transmitting infectious diseases to the health care provider handling these tissues. Accordingly, healthcare providers should employ universal precautions in handling the biopsy samples and the Carticel (autologous cultured chondrocytes for implantation) product.

Pre-surgical Assessment of Comorbidities

The following conditions should be assessed and treated prior to or concurrent with implantation with Carticel (autologous cultured chondrocytes for implantation) :

  1. Unstable meniscus tears should be repaired or resected.
  2. If the patient has had a total meniscectomy, absent meniscus should be reconstructed.
  3. Instability of the knee may adversely affect the success of the procedure and should be corrected. The anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact. It is recommended that cruciate deficiencies be corrected.
  4. Abnormal weight-distribution within the joint may adversely affect the success of the procedure and should be corrected. The tibial/femoral joint should be properly aligned. When treating trochlear defects, abnormal patellar mechanics should be assessed and corrected.

Product Safety and Sterility

The safety of the Carticel (autologous cultured chondrocytes for implantation) product is unknown in patients with malignancy in the area of cartilage biopsy or implant. The potential exists for in vitro expansion and subsequent implantation of malignant or dysplastic cells present in biopsy tissue. In addition, implantation of normal autologous chondrocytes could theoretically stimulate growth of malignant cells in the area of the implant, although there have been no reported incidents in humans or animals.

The Carticel (autologous cultured chondrocytes for implantation) product is shipped following a preliminary sterility test with a 48-hour incubation to determine absence of microbial growth. Final (14 day incubation) sterility test results are not available at the time of implantation.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenicity data are available for Carticel (autologous cultured chondrocytes for implantation) in animals or in humans. No studies on the effects of Carticel (autologous cultured chondrocytes for implantation) on fertility have been conducted.

Use In Specific Populations

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Carticel (autologous cultured chondrocytes for implantation) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 12/22/2010
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.