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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group - sEVs | Experimental | Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosomes (sEVs) | Biological | Exosomes 3-5x10e11 particles/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Ocurrence of any adverse reactions within 12 months of treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of injection-related pain according to VAS scale (0-100mm) | Pain measured by VAS scale after first week of treatment | 1 week |
| Incidence of injection-related sinovitis according to effusion grading scale of knee joint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Matas, MD | Contact | +56 2 26183347 | 3347 | jmatas@clinicauandes.cl |
| Francisco Espinoza, MD | Contact | +56 2 26183347 | 3347 | fespinoza@clinicauandes.cl |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment
| 1 week |
| Pain reduction | Change in VAS score after 52 weeks | 52 weeks |
| Disability reduction | Change in Womac subscale related to function (C) after 52 weeks | 52 weeks |
| Percentage of responders | According to OMERACT-OARSI Criteria Index Response after 52 weeks | 52 weeks |
| D012216 |
| Rheumatic Diseases |