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)

Francisco Espinoza0 sites10 target enrollmentOctober 5, 2021

ConditionsOsteoarthritis, Knee

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Francisco Espinoza
Enrollment: 10
Primary Endpoint: Adverse Event
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 5, 2021

End Date

October 5, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Francisco Espinoza

Responsible Party

Sponsor Investigator

Principal Investigator

Francisco Espinoza

Medical Chieff Officer, Regenero / C4C

Universidad de los Andes, Chile

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adverse Event

Time Frame: 12 months

Ocurrence of any adverse reactions within 12 months of treatment

Secondary Outcomes

Incidence of injection-related sinovitis according to effusion grading scale of knee joint(1 week)
Percentage of responders(52 weeks)
Incidence of injection-related pain according to VAS scale (0-100mm)(1 week)
Pain reduction(52 weeks)
Disability reduction(52 weeks)