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Clinical Trials in the EU / 2026-526179-49-00
Authorised Phase IV

Non-inferiority of surgical treatment of cartilage defects of the knee with autologous minced cartilage implantation (AMCI) and matrix-asscociated autologous chondrocyte implantation with respect to KOOS at 24 months (M ACI) - MinCaRCT

2026-526179-49-00 · tracked via the Priya Life Science EU tracker
Sponsor
Medical Center - University Of Freiburg
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Musculoskeletal Diseases
Decision date
03/08/2026
Enrollment target
166
Sites
Germany

Condition studied

Full-thickness cartilage defects of the knee

Investigational medicinal product(s)

MACI 500000 to 1000000 cells/cm2 implantation matrixSpherox 10-70 spheroids/cm2 implantation suspension

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation

Endpoint detail

Following scores and questionnaires at 3, 6, 12, 24 months after randomisation: IKDC, KOOS5, KOOS subscales (Pain, Symptoms, ADL, Sport and Recreation, QOL), Lysholm, QOL SF-12, absence from work and incidence and number of revision surgeries.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-526179-49-00 on CTIS ↗ ← All trials in the EU