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

Phase 1

Completed

• Conditions: Infarction, Middle Cerebral Artery; Stroke
• Interventions: Genetic: IV infusion of placebo; Genetic: Autologous BMSCs transplantation; Genetic: Autologous EPCs transplantation

• Registration Number: NCT01468064
• Lead Sponsor: Southern Medical University, China

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 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-06
• Study First Posted: 2011-11-09
• Primary Completion: 2015-12
• Study Completion: 2017-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms
2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
3. The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
4. Signed informed consent

Exclusion Criteria

1. Lacunar syndrome
2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
3. Hematological causes of stroke
4. Severe respiratory, hepatic, or renal disorders
5. Presence of severe febrile illness or viral diseases
6. Malignant diseases
7. Presence of autoimmune diseases
8. Positive response of penicillin skin test, or multiple drug allergies
9. Breast-feeding or pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	IV infusion of placebo	-
BMSCs group	Autologous BMSCs transplantation	-
EPCs group	Autologous EPCs transplantation	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events after infusion of BMSCs or EPCs.	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).	1 year

Trial Locations

Locations (1)

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China