The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.
This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule
- The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
- The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.
Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs
- Placebo Comparator Device
Intervention Desc: Normal saline ARM 1: Kind: Experimental Label: SHAM infusion Description: Infusion of normal saline placebo
- MSC Infusion Biological
Intervention Desc: Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset ARM 1: Kind: Experimental Label: MSC infusion Description: Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||maximum tolerated dose (MTD) of IV MSCs||24 hours||Yes|
|Secondary||Improved functional outcome||1 year||No|
- Sean Savitz Lead