NCT05060107UnknownPhase 1
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 enrollmentStarted: October 5, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 10
- Primary Endpoint
- Adverse Event
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Francisco Espinoza
Medical Chieff Officer, Regenero / C4C
Universidad de los Andes, Chile
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