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

Southern Medical University, China20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Infarction, Middle Cerebral Artery

Interventions

Autologous BMSCs transplantationGENETIC

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.

Autologous EPCs transplantationGENETIC

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 placeboGENETIC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of adverse events after infusion of BMSCs or EPCs.

Time frame: 1 year

Secondary Outcomes

Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).

Time frame: 1 year

Data from ClinicalTrials.gov

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