WEDNESDAY, Dec. 14, 2016 — Maci (autologous cultured chondrocytes) has been authorized by the U.S. Meals and Drug Administration to restore faulty cartilage of the knee.
The therapy, derived from wholesome cartilage from the affected person’s personal knee, makes use of tissue engineering to develop cells that change the broken cartilage, the company stated in a information launch.
Cartilage defects generally stem from an damage, knee pressure, overuse, muscle weak point or common wear-and-tear, the FDA stated.
The brand new course of makes use of the affected person’s personal (autologous) cells, that are positioned on a collagen membrane scaffolding that’s surgically implanted over the realm the place broken cartilage was eliminated. The membrane is designed to be absorbed by the physique over time.
The surgeon putting in the implants ought to be skilled within the Maci product. A number of implants can be utilized if there’s multiple defect, the FDA stated.
Maci’s security and effectiveness have been demonstrated throughout a two-year, 144-patient medical research that in contrast the brand new product to an alternate surgical process. Potential negative effects of Maci included joint ache, cold-like signs, headache and again ache.
Maci is produced by Vericel Corp., based mostly in Cambridge, Mass.
Go to the FDA to be taught extra.
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Posted: December 2016