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

Southern Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infarction, Middle Cerebral Artery; Stroke

Treatments: Genetic: IV infusion of placebo; Genetic: Autologous EPCs transplantation; Genetic: Autologous BMSCs transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01468064

2011A030400007 (Other Grant/Funding Number)

ZJH-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups, including a placebo group

BMSCs group

Experimental group

Treatment:

Genetic: Autologous BMSCs transplantation

EPCs group

Experimental group

Treatment:

Genetic: Autologous EPCs transplantation

Control group

Placebo Comparator group

Treatment:

Genetic: IV infusion of placebo