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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
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 2, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
Number of treatment related-adverse events during the study period. [ Time Frame: 180 days after transfusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
Official Title  ICMJE Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Biological: Human umbilical cord mesenchymal stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2015)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02580019
Other Study ID Numbers  ICMJE Hospital307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor  ICMJE Affiliated Hospital to Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Duan Lian, P.H.D Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP