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A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee
This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.
Details
| Lead sponsor | Stempeutics Research Pvt Ltd |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2011-11 |
| Completion | 2014-11 |
Conditions
- Osteoarthritis of Knee
Interventions
- Ex- vivo cultured adult allogeneic MSCs
- Plasmalyte-A
Primary outcomes
- Number and percentage of patients with adverse events as a measure of safety and tolerability — 2 years
* Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording. * Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.
Countries
India