Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Recruiting

Phase 1 Results N/A

Trial Description

Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Detailed Description

For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. The neurological outcome will be determined after transplantation.

Conditions

Interventions

  • Intracerebral stem cell transplantation Genetic
    Intervention Desc: Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
    ARM 1: Kind: Experimental
    Label: intracerebral stem cell transplantation
    Description: Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in NIH Stroke Scale at 12 months 1, 6 and 12 months Yes
Secondary Improvement of infarct size measured by brain MRI 1,6 and 12 months after transplantation No

Sponsors