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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

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.

Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Biological: Human umbilical cord mesenchymal stem cells Phase 1

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 : Interventional
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
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.




Primary Outcome Measures :
  1. Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Improvement of infarct size measured by brain MRI [ Time Frame: before the transplant and 1, 6, 12 months after transplantation ]
  2. Modified Barthel index [ Time Frame: before and 1, 3, 6 and 12 months after transplantation ]
  3. National Institutes of Health stroke scale(NIHSS) score [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02283879


Locations
China, Guangdong
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
The Fifth Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Ping J Chen, Professor The Fifth Affiliated Hospital of Guangzhou Medical University

Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02283879     History of Changes
Other Study ID Numbers: HYK-Cerebral hemorrhage
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Cerebral hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases