Clinical trial NCT01714167: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Keywords: Chronic
Ischemic Stroke
Intracerebral Hemorrhage
Bone Marrow Mesenchymal Stem Cell
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: University of North Texas Health Science Center
First posted: 2012-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in NIH Stroke Scale at 12 months
timeFrame: 1, 6 and 12 months
Secondary outcomes:
measure: Improvement of infarct size measured by brain MRI
timeFrame: 1,6 and 12 months after transplantation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: University of North Texas Health Science Center
name: Kunlin Jin, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Qichuan Zhuge, M.D.
role: STUDY_CHAIR
References: