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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
intracerebral stem cell transplantation
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Chronic, Ischemic Stroke, Intracerebral Hemorrhage, Bone Marrow Mesenchymal Stem Cell

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intracerebral stem cell transplantation

conventional treatment

Arm Description

Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation

Control group receive conventional stroke treatment that include rehabilitation

Outcomes

Primary Outcome Measures

Change from baseline in NIH Stroke Scale at 12 months

Secondary Outcome Measures

Improvement of infarct size measured by brain MRI

Full Information

First Posted
October 19, 2012
Last Updated
June 4, 2015
Sponsor
Wenzhou Medical University
Collaborators
University of North Texas Health Science Center
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1. Study Identification

Unique Protocol Identification Number
NCT01714167
Brief Title
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke
Official Title
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
Collaborators
University of North Texas Health Science Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Chronic, Ischemic Stroke, Intracerebral Hemorrhage, Bone Marrow Mesenchymal Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intracerebral stem cell transplantation
Arm Type
Active Comparator
Arm Description
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation
Arm Title
conventional treatment
Arm Type
No Intervention
Arm Description
Control group receive conventional stroke treatment that include rehabilitation
Intervention Type
Genetic
Intervention Name(s)
intracerebral stem cell transplantation
Intervention Description
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
Primary Outcome Measure Information:
Title
Change from baseline in NIH Stroke Scale at 12 months
Time Frame
1, 6 and 12 months
Secondary Outcome Measure Information:
Title
Improvement of infarct size measured by brain MRI
Time Frame
1,6 and 12 months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qichuan Zhuge, M.D.
Email
zhugeqichuan@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunlin Jin, M.D., Ph.D.
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qichuan Zhuge, M.D.
Organizational Affiliation
First Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

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