The USFDA approves first autologous cellularized scaffold to treat cartilage defects of the knee

Primary tabs

The USFDA approves first autologous cellularized scaffold to treat cartilage defects of the knee

The U.S Food and Drug Administration (USFDA) has given approval for Maci (autologous cultured chondrocytes on the porcine collagen membrane) for the repair of symptomatic, full thickness cartilage defects of the knee in adults. Maci is the first FDA-approved product which was applied to the process of tissue engineering to grow cells on scaffolds using the healthy cartilage tissue from the patient's own knee.

Celia Witten, Ph.D., MD, who is a deputy director of the FDA's Center for Biologics Evaluation and Research has stated that “Different cartilage defects require different treatments, so therapy must be tailored to the patient”. However, the introduction of Maci provides the surgeons with an additional option for the treatment of cartilage defects.

Maci is composed of patient's own cells which were enlarged and placed onto a bio-resorbable (which can be broken down by the body) porcine-derived collagen membrane. This collagen membrane is established over the area where the defective or damaged tissue is removed. Administration should be performed by a surgeon specifically trained in the use of Maci.

Each Maci implant consists of small cellular sheet containing 500,000 to 1,000,000 cells per cm2. The amount of Maci administered depends on the size of the cartilage defect and is trimmed to ensure that the damaged area is completely covered. Multiple implants might be used if there are more than one defect.

The safety and efficacy of Maci were shown in a two-year clinical trial that was designed to demonstrate the reduced pain and improved function in comparison to micro-fracture, an alternative surgical procedure for cartilage repair. The trial included 144 patients. Majority of patients who completed the two-year clinical trial also participated in a three-year follow-up study. ,Overall efficacy data supported a long term clinical benefit from the use of the Maci implanted in the patients with cartilage defects. The most common side effect reported by people receiving Maci included joint pain, common cold-like symptoms, headache and back pain.


FDA Press Announcements

Link to the source:

Original title of article:

FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee

Exploratory, FDA, Autologous cellularized scaffold, Knee, Cartilage, Collagen, Clinical trial, Joint pain, Common cold-like symptoms, Headache, Back pain
Log in or register to post comments