Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke (Recruiting)
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|ClinicalTrials.gov Identifier: NCT02580019|
Recruitment Status : Unknown
Verified July 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : October 20, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Biological: Human umbilical cord mesenchymal stem cells||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
No Intervention: conventional stroke treatment
Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
Biological: 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.
- Number of treatment related-adverse events during the study period. [ Time Frame: 180 days after transfusion ]
- Comparison of National Institutes of Health stroke scale (NIHSS). [ Time Frame: 180 days after the cell treatment. ]
- Comparison of modified Rankin scale (mRS). [ Time Frame: 180 days after the cell treatment. ]
- Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days. [ Time Frame: 180 days after the cell treatment. ]
- Comparison of infarct size measured by brain MRI. [ Time Frame: 180 days after the cell treatment. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580019
|Contact: Li De Sheng, P.H.D||13811435365 ext firstname.lastname@example.org|
|Contact: Huang Min, B.S||18310706110 ext email@example.com|
|Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)|
|Beijing, Beijing, China, 100071|
|Principal Investigator:||Duan Lian, P.H.D||Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China|