Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

September 29, 2015 updated by: Xiaodan Jiang, Southern Medical University, China
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Xiaodan Jiang
        • Contact:
        • Principal Investigator:
          • Xiaodan Jiang, MD,PhD

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-80 chronic ischemia stroke or patients
  • With stroke history of more than 6 months, less than 60 months
  • NIHSS (NIH stroke scale) score of 7 or more points
  • Internal carotid artery territory infarction measured by MRI
  • Can be hospitalized and signed informed consent
  • With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

  • Lacunar infarction
  • Recurrent thrombotic diseases less than 6 months
  • Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
  • Pregnant women
  • Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
  • Penicillin anaphylaxis or some other drugs allergy
  • Autoimmune disease
  • Inaccessibility for follow up

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous stem cell transplantation
Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation
Genetic: Intravenous stem cell transplantation
Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation
No Intervention: Conventional treatment
Control group receive conventional stroke treatment that include rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Fugl-Meyer Scale at 12 months
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in NIH Stroke Scale at 12 months
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months
Change from baseline in SSS at 12 months
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months
Change from baseline in mRS at 12 months
Time Frame: 1,3,6 and 12 months
1,3,6 and 12 months
Improvement of vision measured by brain visual examination
Time Frame: 1,6 and 12 months
1,6 and 12 months

Collaborators and Investigators

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

Sponsor

Southern Medical University, China

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Xiaodan Jiang, MD,PhD, Southern 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

November 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201400000003-2

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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