Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Recruiting

Phase 1 Results N/A

Trial Description

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Detailed Description

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. 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 ischemic stroke. The neurological outcome will be determined after transplantation.

Conditions

Interventions

  • Intravenous stem cell transplantation Drug
    Intervention Desc: Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation
    ARM 1: Kind: Experimental
    Label: Intravenous stem cell transplantation
    Description: Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Fugl-Meyer Scale at 12 months 1,3,6 and 12 months Yes
Secondary Change from baseline in NIH Stroke Scale at 12 months 1,3,6 and 12 months Yes
Secondary Change from baseline in Barthel Index at 12 months 1,3,6 and 12 months Yes
Secondary Change from baseline in SSS at 12 months 1,3,6 and 12 months Yes
Secondary Change from baseline in mRS at 12 months 1,3,6 and 12 months Yes
Secondary Improvement of vision measured by brain visual examination 1,6 and 12 months Yes

Sponsors