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The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.
Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional stroke treatment | No Intervention | Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation | |
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human umbilical cord mesenchymal stem cells | Biological | A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment related-adverse events during the study period. | 180 days after transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of National Institutes of Health stroke scale (NIHSS). | 180 days after the cell treatment. | |
| Comparison of modified Rankin scale (mRS). | 180 days after the cell treatment. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li De Sheng, P.H.D | Contact | 13811435365 | 011-86-126 | deshengli301@126.com |
| Huang Min, B.S | Contact | 18310706110 | 011-86-126 | 871803864@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Duan Lian, P.H.D | Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital) | Beijing | Beijing Municipality | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25449888 | Background | Cheng Q, Zhang Z, Zhang S, Yang H, Zhang X, Pan J, Weng L, Sha D, Zhu M, Hu X, Xu Y. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304. doi: 10.1016/j.brainres.2014.10.065. Epub 2014 Nov 6. | |
| 24444827 | Background |
| Label | URL |
|---|---|
| Human umbilical cord blood-derived mesenchymal stem cell transplantation attenuates severe brain injury by permanent middle cerebral artery occlusion in newborn rats | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| D007511 | Ischemia |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days. |
| 180 days after the cell treatment. |
| Comparison of infarct size measured by brain MRI. | 180 days after the cell treatment. |
| Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18. |
| 23583051 | Background | Verina T, Fatemi A, Johnston MV, Comi AM. Pluripotent possibilities: human umbilical cord blood cell treatment after neonatal brain injury. Pediatr Neurol. 2013 May;48(5):346-54. doi: 10.1016/j.pediatrneurol.2012.10.010. |
| 19938343 | Result | Yalvac ME, Rizvanov AA, Kilic E, Sahin F, Mukhamedyarov MA, Islamov RR, Palotas A. Potential role of dental stem cells in the cellular therapy of cerebral ischemia. Curr Pharm Des. 2009;15(33):3908-16. doi: 10.2174/138161209789649439. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D009336 | Necrosis |