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CHMP adopts positive opinion for Genzyme Europe MACI cartilage product
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The Committee for Medicinal Products for Human Use recently issued a positive opinion that marketing authorization of matrix applied characterized autologous cultured chondrocytes be granted.
Matrix applied characterized autologous cultured chondrocytes (MACI) are implants intended for the repair full-thickness knee cartilage defects in symptomatic adults. The Committee for Medicinal Products for Human Use (CHMP) considered the benefit-to-risk balance for MACI to be positive and therefore recommended MACI for the “repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm2 in skeletally mature adult patients,” according to the CHMP statement.
The applicant was Genzyme Europe BV. MACI is an advanced therapy medicinal product available as an implantation matrix that consists of characterized autologous cultured chondrocytes on a collagen membrane with 500,000 cells per cm2 to 1,000,000 cells per cm2. The prepared matrix is trimmed and implanted into the knee cartilage defect, according to the statement, which explained the MACI implant was investigated in a randomized, open-label parallel-group trial and was compared with microfracture surgery in 144 adults with grade III and IV modified Outerbridge scale knee cartilage defects. The surface area size of defects treated in the study ranged from 3 cm2 to 20 cm2.
The study found MACI superior to microfracture in improving pain and knee function at 104 weeks of follow-up. MACI has been linked to symptomatic graft hypertrophy and graft delamination, as noted in the summary opinion. Patients also may have perioperative complications related to the surgical intervention and a pharmacovigilance plan for MACI will be implemented as part of the marketing authorization.