Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

Shenzhen Hornetcorn Bio-technology Company, LTD20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Hemorrhage

Interventions

Human umbilical cord mesenchymal stem cellsBIOLOGICAL

A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Fifth Affiliated Hospital Immunotherapy center

Guangzhou, Guangdong, China

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

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

Data from ClinicalTrials.gov

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