Dr James Gladstone writes about the first autologous cellularized scaffold approved by FDA

Posted by on Jan 3, 2017 in Dr. James Gladstone, Health | No Comments



Vericel Corporation announced the FDA approval of an autologous cellularized scaffold for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients.

The first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds, each Maci (Vericel Corporation) implant is composed of a patient’s cells that are expanded and placed onto a bioresorbable porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed, according to a press release.

“It’s not prone to overgrowth because it does not have a separate fibrous layer on the surface and it is biodegradable,” Tom Minas, MD, MS, professor of orthopedic surgery at Harvard Medical School and director of the cartilage repair center at the Brigham and Women’s Hospital, told Healio.com/Orthopedics. “It is biodegradable, so the membrane is used basically as a carrier for the cells and the collagen membrane eventually dissolves and disappears, leaving the cells that have been grown and multiplied in the defect that has been transplanted to fill it.”

A company press release noted the approval was based on the SUMMIT, a 2-year prospective, multicenter, randomized, open-label, parallel-group study, that demonstrated a statistically significant greater improvement in KOOS pain and function scores among patients who underwent treatment with the implant compared with patients who underwent microfracture. According to Minas, research also showed patients with cartilage defects of the knee who underwent treatment with the implant experienced clinical benefits in overall efficacy data in an extension study out to 5 years.

Read the full article here: Healio

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