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

Last updated: September 23, 2021
Sponsor: Francisco Espinoza
Overall Status: Active - Not Recruiting

Phase

1

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT05060107
C4C060921
  • Ages 30-70
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 10
Study Start date:
October 05, 2021
Estimated Completion Date:
October 05, 2023