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A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase -I/ II Study Assessing The Safety And Efficacy Of Intravenous Ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells In Patients With Ischemic Cerebral Stroke
This study will evaluate the safety and efficacy of intravenous ex vivo cultured adult allogenic mesenchymal stem cells in patients with ischemic cerebral stroke. Patient will be given single intravenous dose of allogenic mesenchymal stem cells 2 million cells/Kg body weight or placebo within 10 days of stroke. Patients will be followed up till 12 months. Safety will be evaluated by type, number and proportion of patients with adverse events. Efficacy will be evaluated by clinical parameters and MRI.
Details
| Lead sponsor | Stempeutics Research Pvt Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | WITHDRAWN |
| Start date | 2011-12 |
| Completion | 2013-05 |
Conditions
- Stroke
Interventions
- Ex vivo cultured adult allogenic MSCs
- Plasmalyte-A
Primary outcomes
- The type of AE(s), number of AE(s) and proportion of patients with AE(s). — 12 Months
- Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS). — 12 Months
Countries
Malaysia