Infarction, Middle Cerebral Artery, Stroke
Conditions
Keywords
Central Nervous System Diseases, Stroke, Infarction, Middle Cerebral Artery, Cerebral Infarction, Cerebrovascular Accident, Stem Cell Transplantation, Mesenchymal Stem Cell Transplantation, Bone marrow stromal cells, Mesenchymal Stem Cells, Endothelial progenitor cells, Adult Stem Cells, Cell Therapy
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.
Interventions
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.
GENETICAutologous EPCs transplantation
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.
GENETICIV infusion of placebo
IV infusion of saline plus 5% autologous serum.
Sponsors
The Second People's Hospital of Nanhai District of Foshan
The First People's Hospital of Haizhu District Guangzhou
Cellonis Biotechnology Co. Ltd.
Southern Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events after infusion of BMSCs or EPCs. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). | 1 year |
Countries
China
Outcome results
None listed