Vericel Announces First MACI Implant in the United States for the Treatment of Symptomatic Cartilage Defects of the Knee

The FDA approval of MACI was supported by the results of SUMMIT trial1, a Phase 3 two-year, prospective, multicenter, randomized, open-label, parallel-group study that enrolled a total of 144 patients, ages 18 to 54 years, with at least one symptomatic Outerbridge Grade III or IV focal cartila...

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Bibliographic Details
Published inNASDAQ OMX's News Release Distribution Channel
Format Newsletter
LanguageEnglish
Published New York NASDAQ OMX Corporate Solutions, Inc 01.02.2017
Subjects
Arthritis
Back pain
Biopsy
Cartilage
Clinical trials
Collagen
Contraindications
Defects
FDA approval
Infectious diseases
Knee
Osteoarthritis
Patients
Product development
Regulatory approval
Surgeons
Surgery
Tendinitis
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Summary:The FDA approval of MACI was supported by the results of SUMMIT trial1, a Phase 3 two-year, prospective, multicenter, randomized, open-label, parallel-group study that enrolled a total of 144 patients, ages 18 to 54 years, with at least one symptomatic Outerbridge Grade III or IV focal cartilage defect on the medial femoral condyle, lateral femoral condyle, and/or the trochlea. The co-primary efficacy endpoint was change from baseline to Week 104 for the subject's Knee injury and Osteoarthritis Outcome Score (KOOS) in 2 subscales: Pain and Function (Sports and Recreational Activities [SRA]).2 At Week 104, KOOS pain and function (SRA) had improved from baseline in both treatment groups, but the improvement was statistically significantly (p<0.001) greater in the MACI group compared with the microfracture group. In a responder analysis, the proportion of subjects with at least a 10-point improvement in both KOOS pain and function (SRA) was greater in the MACI group (63/72 = 87.5%; 95% CI [77.6%, 94.6%]) compared with the microfracture group (49/72 = 68.1%; 95% CI [56.0%, 78.6%]). Articular cartilage lesions that are left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.3 The prevalence rate for cartilage lesions in the knee has been reported to be 63% in patients undergoing investigational arthroscopies.\n Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel is marketing MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults, which has just been approved by the FDA. Vericel is also developing ixmyelocel-T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM). For more information, please visit the company's website at www.vcel.com.