Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

Cerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02283879
• Other study ID #: HYK-Cerebral hemorrhage
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 3, 2014
• Last updated: May 23, 2016
• Start date: March 2015
• Est. completion date: April 2017

Study information

• Verified date: July 2015
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital Immunotherapy center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	The Fifth Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)		12 months	Yes
Secondary	Improvement of infarct size measured by brain MRI		before the transplant and 1, 6, 12 months after transplantation	No
Secondary	Modified Barthel index		before and 1, 3, 6 and 12 months after transplantation	No
Secondary	National Institutes of Health stroke scale(NIHSS) score		before the transplant and after the transplant 1, 2 and 3 months	No