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| ID | Type | Description | Link |
|---|---|---|---|
| 2011A030400007 | Other Grant/Funding Number | The Key project of Guangdong Science and Technology Program |
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| Name | Class |
|---|---|
| The Second People's Hospital of Nanhai District of Foshan | UNKNOWN |
| The First People's Hospital of Haizhu District Guangzhou | OTHER |
| Cellonis Biotechnology Co. Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMSCs group | Experimental |
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| EPCs group | Experimental |
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| Control group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous BMSCs transplantation | Genetic | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events after infusion of BMSCs or EPCs. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenzhou Chen, MD., phD. | Department of Neurosurgery, Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong | 510282 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20506226 | Background | 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. | |
| 15929052 | Background | Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501. |
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| Autologous EPCs transplantation | Genetic | 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. |
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| IV infusion of placebo | Genetic | IV infusion of saline plus 5% autologous serum. |
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| 30156755 | Derived | Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020244 | Infarction, Middle Cerebral Artery |
| D002493 | Central Nervous System Diseases |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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