Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study

EXO-OA01

The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months.

2024-06-01

2025-06-30

2025-12-31

Recruiting

Early phase I

12

Inclusion Criteria: * Age 30 to 70 years. * Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray) * VAS for pain ≥ 40 mm, without surgical indication in the affected knee. * In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm. * Stable knee with normal physical examination. * Signed Informed Consent Exclusion Criteria: * Symptomatic bilateral knee OA * BMI \> 30 kg/m2 * Joint instability at physical examination. * Mechanical meniscal tear on physical examination. * Associated conditions: active local or systemic infection, neoplasia, immunosuppression, pregnancy, anticoagulant therapy, coagulation disorders, inflammatory joint disease (autoimmune, by crystal or other), joint prosthesis, symptomatic spine or hip disease. * Recent use of intra-articular (last 6 months) or oral (last month) steroid therapy. * Recent use of intra-articular hyaluronic acid therapy (last 6 months) * Subchondral bone fracture.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-05-29