Mesenchymal Stromal Cells for Ischemic Stroke "SAMCIS"

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

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.

Detailed Description

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
Objectives:
- 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

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary maximum tolerated dose (MTD) of IV MSCs 24 hours Yes
Secondary Improved functional outcome 1 year No

Sponsors