Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke
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ClinicalTrials.gov Identifier: NCT01714167 |
Recruitment Status : Unknown
Verified June 2015 by Qichuan Zhuge, Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : October 25, 2012
Last Update Posted : June 8, 2015
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Condition or disease | Intervention/treatment | Phase |
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Stroke | Genetic: intracerebral stem cell transplantation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke |
Study Start Date : | June 2012 |
Estimated Primary Completion Date : | October 2015 |
Estimated Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
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
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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
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- Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: 1, 6 and 12 months ]
- Improvement of infarct size measured by brain MRI [ Time Frame: 1,6 and 12 months after transplantation ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714167
Contact: Qichuan Zhuge, M.D. | zhugeqichuan@vip.163.com |
China, Zhejiang | |
The First Affiliated Hospital of Wenzhou Medical College | Recruiting |
Wenzhou, Zhejiang, China, 32500 |
Study Director: | Kunlin Jin, M.D., Ph.D. | University of North Texas Health Science Center | |
Study Chair: | Qichuan Zhuge, M.D. | First Affiliated Hospital of Wenzhou Medical University |
Responsible Party: | Qichuan Zhuge, Department of Neurosurgery, Wenzhou Medical University |
ClinicalTrials.gov Identifier: | NCT01714167 |
Other Study ID Numbers: |
WZMC-2011-8 |
First Posted: | October 25, 2012 Key Record Dates |
Last Update Posted: | June 8, 2015 |
Last Verified: | June 2015 |
Chronic Ischemic Stroke Intracerebral Hemorrhage Bone Marrow Mesenchymal Stem Cell |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |