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

Osteoarthritis, Knee Clinical Trial

— ExoOA-1  

Official title:

A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05060107
• Other study ID #: C4C060921
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 5, 2021
• Est. completion date: October 5, 2023

Study information

• Verified date: September 2021
• Source: Universidad de los Andes, Chile
• Contact: Jose Matas, MD
• Phone: +56 2 26183347
• Email: jmatas[@]clinicauandes.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Exosomes (sEVs)
Exosomes 3-5x10e11 particles/dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Francisco Espinoza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event	Ocurrence of any adverse reactions within 12 months of treatment	12 months
Secondary	Incidence of injection-related pain according to VAS scale (0-100mm)	Pain measured by VAS scale after first week of treatment	1 week
Secondary	Incidence of injection-related sinovitis according to effusion grading scale of knee joint	Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment	1 week
Secondary	Pain reduction	Change in VAS score after 52 weeks	52 weeks
Secondary	Disability reduction	Change in Womac subscale related to function (C) after 52 weeks	52 weeks
Secondary	Percentage of responders	According to OMERACT-OARSI Criteria Index Response after 52 weeks	52 weeks