Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage

Shenzhen Hornetcorn Bio-technology Company, LTD1 site in 1 country20 target enrollmentMarch 2015

ConditionsCerebral Hemorrhage

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cerebral Hemorrhage
Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Enrollment: 20
Locations: 1
Primary Endpoint: Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

April 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)

Time Frame: 12 months

Secondary Outcomes

Improvement of infarct size measured by brain MRI(before the transplant and 1, 6, 12 months after transplantation)
National Institutes of Health stroke scale(NIHSS) score(before the transplant and after the transplant 1, 2 and 3 months)
Modified Barthel index(before and 1, 3, 6 and 12 months after transplantation)