Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Condition: Stroke; Infarction, Middle Cerebral Artery
MeSH terms: Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous
      transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial
      progenitor cells (EPCs) for treatment of patients with ischemic stroke.
    

Detailed description: 
      This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients
      with acute cerebral infarcts within the middle cerebral arterial territory and with severe
      neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs
      transplantation group, autologous EPCs transplantation group and Placebo control group.
      Randomization codes were established by the study statistician and were revealed only to the
      stem cell laboratory technician responsible for separating the cells into aliquots or
      preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure
      at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously
      infused into own body, respectively. The control group will not receive cell therapy. Observe
      will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality
      of any cause, side effects, and new-onset comorbidities will be monitored and compared
      between each groups.
    

Intervention name(s): Autologous BMSCs transplantation; Autologous EPCs transplantation; IV infusion of placebo
Intervention type(s): Genetic; Genetic; Genetic
Intervention description(s): The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.; The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.; IV infusion of saline plus 5% autologous serum.
Other intervention name(s): Autologous Bone marrow stromal cells transplantation; Autologous Mesenchymal stem cells transplantation; Autologous endothelial progenitor cells transplantation; Placebo control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Central Nervous System Diseases; Stroke; Infarction, Middle Cerebral Artery; Cerebral Infarction; Cerebrovascular Accident; Stem Cell Transplantation; Mesenchymal Stem Cell Transplantation; Bone marrow stromal cells; Mesenchymal Stem Cells; Endothelial progenitor cells; Adult Stem Cells; Cell Therapy