Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
|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
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Hemorrhage||Biological: Human umbilical cord mesenchymal stem cells||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) [ Time Frame: 12 months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283879
|The Fifth Affiliated Hospital Immunotherapy center|
|Guangzhou, Guangdong, China, 510000|
|Principal Investigator:||Ping J Chen, Professor||The Fifth Affiliated Hospital of Guangzhou Medical University|