drugset / Trial / NCT02580695
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.
Timeline
- Start
- 2015-12
- Primary completion
- 2017-01
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hyaluronic Acid | Other / unclassified | 3 ml | Other |
| Subject | mesenchymal stem cells | Cell therapy | 2e+07 cells | Other |