Clinical Trial: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

Brief 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 Summary: 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.
Sponsor: Southern Medical University, China

Current Primary Outcome: Number of adverse events after infusion of BMSCs or EPCs. [ Time Frame: 1 year ]

Original Primary Outcome: Safety evaluation and tolerability of a single treatment administration of autologous cultured bone marrow stromal cells and endothelial progenitor cells. [ Time Frame: 1 year ]

Current Secondary Outcome: Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Southern Medical University, China

Dates:
Date Received: November 2, 2011
Date Started: November 2011
Date Completion: March 2017
Last Updated: November 12, 2015
Last Verified: November 2015