Trials / Unknown
UnknownNCT05060107
Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-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)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Francisco Espinoza · Academic / Other
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Exosomes (sEVs) | Exosomes 3-5x10e11 particles/dose |
Timeline
- Start date
- 2021-10-05
- Primary completion
- 2023-04-05
- Completion
- 2023-10-05
- First posted
- 2021-09-28
- Last updated
- 2021-09-28
Source: ClinicalTrials.gov record NCT05060107. Inclusion in this directory is not an endorsement.