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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

This study is currently recruiting participants.
Verified October 2012 by Wenzhou Medical College
Sponsor:
Collaborator:
University of North Texas Health Science Center
Information provided by (Responsible Party):
Qichuan Zhuge, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01714167
First received: October 19, 2012
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.


Condition Intervention Phase
Stroke
 Genetic: intracerebral stem cell transplantation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:
  • Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of infarct size measured by brain MRI [ Time Frame: 1,6 and 12 months after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intracerebral stem cell transplantation
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation
 Genetic: intracerebral stem cell transplantation
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
No Intervention: conventional treatment
Control group receive conventional stroke treatment that include rehabilitation

Detailed Description:

For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
  • With stroke history of more than 3 months, less than 60 months
  • With stable hemiplegia condition
  • NIHSS (NIH stroke scale) 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:

  • Patients aged less than 40 or more than 70
  • Lacunar infarction
  • History of neurological disease, head injury or psychiatric disorder with disablity
  • Pregnant women
  • Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
  • Inaccessibility for follow up
  • Unwillingness to provide written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714167

Contacts
Contact: Qichuan Zhuge, M.D. zhugeqichuan@vip.163.com

Locations
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 32500
Sponsors and Collaborators
Wenzhou Medical College
University of North Texas Health Science Center
Investigators
Study Director: Kunlin Jin, M.D., Ph.D. University of North Texas Health Science Center
Study Chair: Qichuan Zhuge, M.D. Wenzhou Medical College
  More Information

No publications provided

Responsible Party: Qichuan Zhuge, Department of Neurosurgery, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01714167     History of Changes
Other Study ID Numbers: WZMC-2011-8
Study First Received: October 19, 2012
Last Updated: October 22, 2012
Health Authority: China: Ethics Committee

Keywords provided by Wenzhou Medical College:
Chronic
Ischemic Stroke
Intracerebral Hemorrhage
Bone Marrow Mesenchymal Stem Cell

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 21, 2013