Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 stroke
Started Jun 2012
Typical duration for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 8, 2015
June 1, 2015
3.3 years
October 19, 2012
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in NIH Stroke Scale at 12 months
1, 6 and 12 months
Secondary Outcomes (1)
Improvement of infarct size measured by brain MRI
1,6 and 12 months after transplantation
Study Arms (2)
intracerebral stem cell transplantation
ACTIVE COMPARATORIntracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation
conventional treatment
NO INTERVENTIONControl group receive conventional stroke treatment that include rehabilitation
Interventions
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 32500, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Neurosurgery
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 25, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
June 8, 2015
Record last verified: 2015-06