EMA Says No to Knee Cartilage Repair Therapy Jelrix

At its July 2025 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended refusing marketing authorization for Jelrix (autologous cartilage-derived articular chondrocytes), a product intended to repair injury-related cartilage defects in the knee.

Jelrix is an advanced therapy medicinal product that uses a patient’s own cartilage cells that are expanded in a lab and then implanted back into the knee to repair the defect. It was developed for patients with symptomatic cartilage defects of 2 cm² to 12 cm² whose bones have finished growing.

In its decision, the EMA cited concerns about the lack of data to ensure consistent quality of the medicine through its manufacturing process and control strategy.

No Verifiable Improvement

The application was supported by a main study involving 100 patients with cartilage defects in the knee. The primary effectiveness measure was the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, and quality of life on a 0-100 scale, with higher scores indicating fewer symptoms. Assessments were conducted at 24 and 60 months post-treatment. Results were compared indirectly to outcomes from a separate microfracture registry rather than via a randomized control group. 

While patients who received Jelrix showed improvement in their KOOS scores at 24 and 60 months, the EMA noted that the study lacked a comparator group. This means the improvements could not be definitively attributed to Jelrix, as they might have resulted from the surgery and rehabilitation all participants received. Therefore, the agency concluded that the benefits of Jelrix did not outweigh its risks.

The company confirmed there are no ongoing clinical trials or compassionate use/expanded access programs involving Jelrix in the EU.

The applicant, Tissue Engineering Technologies AG, may request reexamination within 15 calendar days of receiving EMA’s opinion. If pursued, CHMP will reassess their application based on any additional data provided.