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

Phase 1

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: Exosomes (sEVs)

• Registration Number: NCT05060107
• Lead Sponsor: Francisco Espinoza

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Last Update Submitted: 2021-09-23
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Study Start: 2021-10-05
• Primary Completion: 2023-04-05
• Study Completion: 2023-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group - sEVs	Exosomes (sEVs)	Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.

Primary Outcome Measures

Name	Time	Method
Adverse Event	12 months	Ocurrence of any adverse reactions within 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Pain reduction	52 weeks	Change in VAS score after 52 weeks
Incidence of injection-related sinovitis according to effusion grading scale of knee joint	1 week	Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment
Percentage of responders	52 weeks	According to OMERACT-OARSI Criteria Index Response after 52 weeks
Incidence of injection-related pain according to VAS scale (0-100mm)	1 week	Pain measured by VAS scale after first week of treatment
Disability reduction	52 weeks	Change in Womac subscale related to function (C) after 52 weeks