NCT06431152 Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis
| NCT ID | NCT06431152 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Universidad de los Andes, Chile |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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) * Subchon