Subscribe or Manage Preferences
VBCR - December 2016, Vol 5, No 6 - FDA News & Updates

Maci Approved for the Reparation of Cartilage Defects

On December 13, 2016, the FDA approved Maci, a cellular scaffold comprised of autologous cultured chondrocytes on porcine collagen membrane (Vericel Corporation), for the reparation of symptomatic knee cartilage defects in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

Knee cartilage damage can occur as a result of muscle weakness, overuse, general wear and tear, straining beyond normal motion, or injury.

“Different cartilage defects require different treatments, so therapy must be tailored to the patient. The introduction of Maci provides surgeons with an additional option for treatment,” said Celia Witten, PhD, MD, Deputy Director, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD.

Maci is constructed using a patient’s own cells, which are then extended and placed on a bioresorbable collagen membrane that is derived from porcine. Every Maci implant comprises a small sheet that contains 500,000 to 1,000,000 cells per cm2. The membrane is then surgically implanted over the section of the patient’s knee where damaged tissue was removed.

The FDA advises that administration of Maci should be performed by a surgeon who has been specifically trained in how to use this cellular scaffold. Maci can be trimmed down to size according to the extent of the cartilage defect, ensuring that the damaged section is covered entirely. In cases where >1 defect is present, multiple implants can be used.

According to results of a 2-year trial comparing the use of Maci with micro­fracture (an alternative surgical procedure for repairing cartilage), patients with cartilage defects experience long-term benefits from the use of the Maci implant.

Joint pain, back pain, headache, and symptoms similar to those of a common cold were the most common side effects reported by patients who received a Maci implant.

Related Items
FDA News - December 2017
VBCR - December 2017, Vol 6, No 5 published on December 19, 2017 in FDA News & Updates
FDA News - October 2017
VBCR - October 2017, Vol 6, No 4 published on October 20, 2017 in FDA News & Updates
Scott Gottlieb, MD, Appointed as New FDA Commissioner
VBCR - June 2017, Vol 6, No 2 published on June 29, 2017 in FDA News & Updates
New Drugs Approved for Giant-Cell Arteritis and Moderate-to-Severe Rheumatoid Arthritis
VBCR - June 2017, Vol 6, No 2 published on June 29, 2017 in FDA News & Updates
FDA Releases Draft Guidances on Sharing Healthcare Economic Information, Industry Communication Regulations
Leslie Wyatt
VBCR - April 2017, Vol 6, No 1 published on May 3, 2017 in FDA News & Updates
FDA Approves First Tissue-Engineered Autologous Cellularized Scaffold Product for the Repair of Cartilage Defects
In the News: Value-Based Care - December 2016 published on December 15, 2016 in FDA News & Updates
FDA News - November 2016
VBCN - November 2016 Volume 3, No 3 published on November 22, 2016 in FDA News & Updates
Abuse-Deterrent Oxycodone Extended-Release Capsules Approved for Chronic Pain
In the News: Value-Based Care - November 2016 published on November 7, 2016 in FDA News & Updates
FDA News - October 2016
VBCR - October 2016, Vol 5, No 5 published on November 2, 2016 in FDA News & Updates
Adalimumab Biosimilar Approved for Multiple Inflammatory Indications
In the News: Value-Based Care - September 2016 published on September 27, 2016 in FDA News & Updates
Last modified: February 1, 2017
  • Rheumatology Practice Management
  • Lynx CME
  • American Health & Drug Benefits
  • Value-Based Cancer Care
  • Value-Based Care in Myeloma
  • Value-Based Care in Neurology