Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

May 23, 2016 updated by: Shenzhen Hornetcorn Bio-technology Company, LTD

Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The Fifth Affiliated Hospital Immunotherapy center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of infarct size measured by brain MRI
Time Frame: before the transplant and 1, 6, 12 months after transplantation
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
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
before the transplant and after the transplant 1, 2 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

The Fifth Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Ping J Chen, Professor, The Fifth Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYK-Cerebral hemorrhage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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