Clinical Trial: Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

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

Original Primary Outcome: Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ]

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Shenzhen Hornetcorn Bio-technology Company, LTD

Dates:
Date Received: November 3, 2014
Date Started: March 2015
Date Completion: April 2017
Last Updated: May 23, 2016
Last Verified: July 2015