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Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

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ClinicalTrials.gov Identifier: NCT02283879
Recruitment Status : Unknown
Verified July 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
The Fifth Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Tracking Information
First Submitted Date  ICMJE November 3, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ]
Change History Complete list of historical versions of study NCT02283879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • Improvement of infarct size measured by brain MRI [ Time Frame: before the transplant and 1, 6, 12 months after transplantation ]
  • Modified Barthel index [ Time Frame: before and 1, 3, 6 and 12 months after transplantation ]
  • National Institutes of Health stroke scale(NIHSS) score [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Improvement of infarct size measured by brain MRI [ Time Frame: before the transplant and 1, 6, 12 months after transplantation ]
  • Modified Barthel index [ Time Frame: 1, 3, 6 and 12 months after transplantation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Official Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Brief Summary The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
Detailed Description

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.

To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Hemorrhage
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 Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Intervention: Biological: Human umbilical cord mesenchymal stem cells
Publications * Not Provided

*   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: November 3, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 40-70 intracerebral hemorrhage patient
  • With stroke history of more than 3 months, less than 60 months
  • National Institutes of Health stroke scale(NIHSS) score of 7 or more points
  • Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

  • History of neurological disease, head injury or psychiatric disorder;
  • Pregnant women;
  • Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
  • Progressive apoplexy;
  • With malignant tumors.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02283879
Other Study ID Numbers  ICMJE HYK-Cerebral hemorrhage
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shenzhen Hornetcorn Bio-technology Company, LTD
Study Sponsor  ICMJE Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators  ICMJE The Fifth Affiliated Hospital of Guangzhou Medical University
Investigators  ICMJE
Principal Investigator: Ping J Chen, Professor The Fifth Affiliated Hospital of Guangzhou Medical University
PRS Account Shenzhen Hornetcorn Bio-technology Company, LTD
Verification Date July 2015

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