Status:
COMPLETED
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Lead Sponsor:
Southern Medical University, China
Collaborating Sponsors:
The Second People's Hospital of Nanhai District of Foshan
The First People's Hospital of Haizhu District Guangzhou
Conditions:
Stroke
Infarction, Middle Cerebral Artery
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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...
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 defi...
Eligibility Criteria
Inclusion
- Patients aged 18 to 80 years, within 7 days of the onset of symptoms
- Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
- The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
- Signed informed consent
Exclusion
- Lacunar syndrome
- Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
- Hematological causes of stroke
- Severe respiratory, hepatic, or renal disorders
- Presence of severe febrile illness or viral diseases
- Malignant diseases
- Presence of autoimmune diseases
- Positive response of penicillin skin test, or multiple drug allergies
- Breast-feeding or pregnant women
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01468064
Start Date
November 1 2011
End Date
March 1 2017
Last Update
April 2 2021
Active Locations (1)
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1
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510282