Date: 2015-03-25
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Academy of Orthopedic Surgeons annual meeting in Las Vegas, Nevada starting on Tuesday, March 24, 2015
Company: Vericel Corporation (formerly Aastrom Biosciences) (USA - MI)
Product: MACI™ (Matrix applied characterised autologous cultured chondrocytes)
Action
mechanism: cell therapy. MACI™ is a cell therapy product. This advanced therapy medicinal product (ATMP) is to be available as an implantation matrix consisting of characterised autologous cultured chondrocytes on a collagen membrane (500,000 to 1,000,000 cells per cm2), to be trimmed and implanted into the cartilage defect of the damaged knee.
Disease: cartilage defects of the knee
Therapeutic area: Rheumatic diseases
Country:
Trial details:
Latest
news: * On March 25, 2015, Vericel Corporation, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, reported that positive results from the three-year extension of the Phase 3 SUMMIT study with MACI™ (matrix-applied characterized autologous cultured chondrocytes) were presented at the annual meeting of the American Association of Orthopedic Surgeons in Las Vegas. In a poster presentation (number P169) entitled "SUMMIT Trial: Matrix-induced Autologous Chondrocyte Implant versus Microfracture at 3 Years," Professor Mats Brittberg, Cartilage Research Unit, University of Gothenburg, Sweden, and colleagues reported that patients followed for three years following treatment with MACI had consistent results as those reported previously in the two-year SUMMIT trial. * On September 16, 2014, Aastrom Biosciences announced that three-year results from the SUMMIT extension study on the clinical efficacy and safety of matrix-applied characterized autologous chondrocytes (MACI™) for treating cartilage defects will be presented in a poster session at the American Academy of Orthopedic Surgeons annual meeting in Las Vegas, Nevada starting on Tuesday, March 24, 2015. The poster is entitled \"SUMMIT Extension: Matrix-induced Autologous Chondrocyte Implant vs Microfracture at 3 Years.\" Two-year results from the initial phase 3, randomized, controlled SUMMIT trial demonstrated that patients with symptomatic articular cartilage defects of the knee who were treated with MACI™ showed greater improvement over baseline compared to patients treated with microfracture (Saris D, et al. Am J Sports Med. 2014 Apr 8 [Epub]). The accepted poster by authors D. Saris, A. Price, Q. Yu, S. Kili, and M. Brittberg will provide analysis of the three-year clinical efficacy and safety of the MACI™ implant for treating cartilage defects. Last April, Aastrom Biosciences has entered into a definitive agreement to acquire Sanofi\'s Cell Therapy and Regenerative Medicine (CTRM) business for a purchase price of $6.5 million, with $4 million payable in cash at closing and $2.5 million payable in the form of a promissory note. Through this acquisition, Aastrom acquired MACI™ (matrix-applied characterized autologous cultured chondrocytes), which is approved in the European Union and is a Phase 3 product candidate in the United States.
In the open-label, multi-center Phase 3 SUMMIT study, 144 patients with symptomatic articular cartilage defects in the knee were randomized to receive treatment with MACI implant or microfracture bone marrow stimulation (MFX) and followed for two years. The study found that treatment with MACI was clinically and statistically significantly better than MFX, with similar structural repair tissue and safety. The SUMMIT study concluded that "MACI offers a more efficacious alternative than MFX with a similar safety profile for the treatment of symptomatic articular cartilage defects of the knee."
In the SUMMIT Extension trial, 128 patients (men and women aged 18 to 55) from the original SUMMIT study continue to be followed. The co-primary endpoints of the extension study are change in knee injury and osteoarthritis outcome (KOOS) pain and function scores at year 3, the same primary endpoint from the two-year SUMMIT trial. Patients treated with MACI versus MFX continue to show a statistically significant improvement from baseline in the co-primary endpoint of KOOS pain and function at year 3 (p = 0.046) with higher responder rates in the MACI group (81.5%) than in the MFX group (66.7%). Patients treated with MACI versus MFX also showed significant improvement in knee-related quality of life and other measures. The authors concluded that "the co-primary endpoints of pain and function showed significant improvement with MACI, which was statistically significantly better than with MFX." The incidences of treatment emergent adverse events and serious adverse events were similar between treatment groups at year 3 and no unexpected safety findings were reported. Vericel plans to meet with the FDA this year to discuss the requirements for registration of MACI in the United States.
