This trial is active, not recruiting.

Condition cerebral hemorrhage
Treatment human umbilical cord mesenchymal stem cells
Phase phase 1
Sponsor Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborator The Fifth Affiliated Hospital of Guangzhou Medical University
Start date March 2015
End date December 2016
Trial size 20 participants
Trial identifier NCT02283879, HYK-Cerebral hemorrhage


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
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.

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

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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.

Additional Information

Official title Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Principal investigator Ping J Chen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Shenzhen Hornetcorn Bio-technology Company, LTD.