Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis

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

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.

Conditions2

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