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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01468064
Other study ID # ZJH-001
Secondary ID 2011A030400007
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2011
Est. completion date March 2017

Study information

Verified date April 2021
Source Southern Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Genetic:
Autologous BMSCs transplantation
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 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.
IV infusion of placebo
IV infusion of saline plus 5% autologous serum.

Locations

Country Name City State
China Zhujiang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (4)

Lead Sponsor Collaborator
Southern Medical University, China Cellonis Biotechnology Co. Ltd., The First People's Hospital of Haizhu District Guangzhou, The Second People's Hospital of Nanhai District of Foshan

Country where clinical trial is conducted

China, 

References & Publications (2)

Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. — View Citation

Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events after infusion of BMSCs or EPCs. 1 year
Secondary Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). 1 year
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