Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

Withdrawn

Phase 1/2 Results N/A

Trial Description

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.

Trial Stopped: Business reasons

Conditions

Interventions

  • Ex vivo cultured adult allogenic MSCs Biological
    Intervention Desc: Single IV dose of allogenic MSCs
    ARM 1: Kind: Experimental
    Label: Ex vivo cultured adult allogenic MSCs
  • Plasmalyte-A Other
    Intervention Desc: Single IV dose of Plasmalyte-A
    ARM 1: Kind: Experimental
    Label: Plasmalyte-A

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 The type of AE(s), number of AE(s) and proportion of patients with AE(s). 12 Months Yes
Primary Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS). 12 Months No
Secondary Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living. 12 Months No
Secondary Improvement of Global outcome as assessed by the Modified Rankin Scale 12 Months No
Secondary MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index 12 Months No
Secondary Improvement of Global outcome as assessed by the Modified Rankin Scale 12 Months No

Sponsors