Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

AAG-G-H-1703

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

2018-11-30

2025-12-01

2028-12-01

Recruiting

Early phase I

30

Inclusion Criteria: * participated in study AAG-G-H-1220 * identified as a microfracture failure patient * voluntary consent to participate in the study Exclusion Criteria: * other cartilage repair procedures performed on target knee * other conditions that would interfere with healing or evaluating outcomes * lesions requiring implants larger than 9cm2 * non-compliance with requirements in study AAG-G-H-1220

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-13