Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
NCT ID: NCT02580019
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
2 participants
INTERVENTIONAL
2016-02-29
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional stroke treatment
Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
No interventions assigned to this group
hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
Interventions
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Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
Eligibility Criteria
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Inclusion Criteria
* Patients have received proper treatment within two weeks from the onset of stroke symptoms.
* Age between 18 to 70 years old for men or women
* Patients with persistent neurological deficit .
* Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
* Patients basic situation are allowable to be involved in the program.
Exclusion Criteria
* Patients with serious persistent neurological deficit (NIHSS \> 24).
* Medical history of neurological pathology with a deficit as consequence (Rankin \< 3 before stroke).
* Patients with serious psychological disease.
* Patients with myocardial infarction in recent 3 months.
* Patients with recurring thromboembolic disease in recentin recent 3 months.
* Patients with organ transplantation.
* Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
* Patients receive current immunosuppressive/immunomodulating treatment.
* Patients basic situation are unallowable to be involved in the program.
* Patients who refuse to participate.
* Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
* Patients who are pregnant or feeding women.
* Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
18 Years
70 Years
ALL
Yes
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Duan Lian, P.H.D
Role: PRINCIPAL_INVESTIGATOR
Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
Locations
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Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
Related Links
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This review article provides an update role of hUC-MSCs implantation in the treatment of ischemic stroke.
Human umbilical cord blood-derived mesenchymal stem cell transplantation attenuates severe brain injury by permanent middle cerebral artery occlusion in newborn rats
Other Identifiers
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Hospital307
Identifier Type: -
Identifier Source: org_study_id