Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke (Recruiting)

November 30, 2015 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke

The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.

Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Huang Min, B.S
  • Phone Number: 011-86-126 18310706110
  • Email: 871803864@qq.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
  • Patients have received proper treatment within two weeks from the onset of stroke symptoms.
  • Age between 18 to 70 years old for men or women
  • Patients with persistent neurological deficit .
  • Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
  • Patients basic situation are allowable to be involved in the program.

Exclusion Criteria:

  • Patients with serious extensive stroke, who are unwilling to the risk.
  • Patients with serious persistent neurological deficit (NIHSS > 24).
  • Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
  • Patients with serious psychological disease.
  • Patients with myocardial infarction in recent 3 months.
  • Patients with recurring thromboembolic disease in recentin recent 3 months.
  • Patients with organ transplantation.
  • Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
  • Patients receive current immunosuppressive/immunomodulating treatment.
  • Patients basic situation are unallowable to be involved in the program.
  • Patients who refuse to participate.
  • Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Patients who are pregnant or feeding women.
  • Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional stroke treatment
Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
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
Number of treatment related-adverse events during the study period.
Time Frame: 180 days after transfusion
180 days after transfusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of National Institutes of Health stroke scale (NIHSS).
Time Frame: 180 days after the cell treatment.
180 days after the cell treatment.
Comparison of modified Rankin scale (mRS).
Time Frame: 180 days after the cell treatment.
180 days after the cell treatment.
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
Time Frame: 180 days after the cell treatment.
180 days after the cell treatment.
Comparison of infarct size measured by brain MRI.
Time Frame: 180 days after the cell treatment.
180 days after the cell treatment.

Collaborators and Investigators

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Duan Lian, P.H.D, Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

October 17, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital307

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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