Back to resultsHuman Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Primary Purpose
Cerebral Hemorrhage
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Hemorrhage focused on measuring Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Cerebral hemorrhage
Eligibility 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.
Sites / Locations
- The Fifth Affiliated Hospital Immunotherapy center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hUC-MSC treatment
Arm Description
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Outcomes
Primary Outcome Measures
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Secondary Outcome Measures
Improvement of infarct size measured by brain MRI
Modified Barthel index
National Institutes of Health stroke scale(NIHSS) score
Full Information
NCT ID
NCT02283879
First Posted
November 3, 2014
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02283879
Brief Title
Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Official Title
Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hemorrhage
Keywords
Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Cerebral hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hUC-MSC treatment
Arm Type
Experimental
Arm Description
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Intervention Type
Biological
Intervention Name(s)
Human umbilical cord mesenchymal stem cells
Intervention Description
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
Primary Outcome Measure Information:
Title
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement of infarct size measured by brain MRI
Time Frame
before the transplant and 1, 6, 12 months after transplantation
Title
Modified Barthel index
Time Frame
before and 1, 3, 6 and 12 months after transplantation
Title
National Institutes of Health stroke scale(NIHSS) score
Time Frame
before the transplant and after the transplant 1, 2 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping J Chen, Professor
Organizational Affiliation
Fifth Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Affiliated Hospital Immunotherapy center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
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