Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1)

Francisco Espinoza

Status and phase: Unknown; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Biological: Exosomes (sEVs)

Study type: Interventional

Funder types: Other

Identifiers

NCT05060107

C4C060921

Details and patient eligibility

About

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. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.

Enrollment: 10 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic knee OA with VAS >50mm
• Knee OA Kellgren-Lawrence grade II to III
• Chondromalacia grade I to III
• Stable joint

Exclusion criteria

• Bilateral symptomatic knee OA
• Local infection
• Neoplasia
• Joint replacement
• Recent use of local steroids
• BMI > 30

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Experimental group - sEVs

Experimental group

Description:

Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.

Treatment:

Biological: Exosomes (sEVs)