Intravenous Stem Cells After Ischemic Stroke "ISIS"

Completed

Phase 2 Results N/A

Trial Description

The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).

Detailed Description

Stroke is the leading cause of acquired adult disability. Except the hospitalization in stroke units, only thrombolysis has been shown to be efficient to treat acute ischemic stroke in the first three hours after the onset. Increasing brain plasticity after stroke represents an important alternative strategy. Cell therapy provides a functional improvement after cerebral ischemia in rodent models. This "restorative" therapy aims to replace destroyed cerebral tissue with a stem cells graft. Despite these encouraging experiments, we do not know yet the best way of administration of the stem cells, the best dose and the optimal delay of the graft. The pioneer clinical studies failed to reproduce this benefit for patients probably because of the limited number of studied patients. Therefore, more translational studies are needed to improve our knowledge in this promising field. Among different cell sources, mesenchymal (or stromal) stem cells (MSC) derived from bone marrow offer the advantage of arising from a non tumoral and no modified source and are not sources of immunological or ethical problems.
Our research project involves a development of cell therapy in a phase IIa clinical trial of feasibility and safety in patients (randomised, controlled, open, with 3 parallel groups).

Conditions

Interventions

  • Autologous mesenchymal stem cells Genetic
    Intervention Desc: Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke
    ARM 1: Kind: Experimental
    Label: 2
    Description: First dose of stem cells
    ARM 2: Kind: Experimental
    Label: 3
    Description: Second dose of stem cells

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke 2 weeks, 1, 2, 4, 6 months and 1, 2 years Yes
Secondary Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke 2 weeks, 1, 2, 4, 6 months and 1, 2 years Yes
Secondary Determination of the most effective dose of stem cells 2 weeks, 1, 2, 4, 6 months and 1, 2 years No
Secondary To define the best criteria for a future trial (phase III) 2 weeks, 1, 2, 4, 6 months and 1, 2 years No
Secondary To define the best target population for a future study 2 weeks, 1, 2, 4, 6 months and 1, 2 years No

Sponsors