Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
Recruiting
Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
1 other identifier
interventional
2
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 2, 2015
July 1, 2015
10 months
July 2, 2015
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of treatment related-adverse events during the study period.
180 days after transfusion
Secondary Outcomes (4)
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.
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.
Study Arms (2)
conventional stroke treatment
NO INTERVENTIONControl group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
hUC-MSC treatment
EXPERIMENTALPatients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
Interventions
A single dose of 2Ă—107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
- 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.
You may not qualify if:
- Patients with serious extensive stroke, who are unwilling to the risk.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
Beijing, Beijing Municipality, 100071, China
Related Publications (4)
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.
PMID: 25449888BACKGROUNDTsuji 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.
PMID: 24444827BACKGROUNDVerina 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.
PMID: 23583051BACKGROUNDYalvac 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.
PMID: 19938343RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duan Lian, P.H.D
Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2015
First Posted
October 20, 2015
Study Start
February 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
December 2, 2015
Record last verified: 2015-07