Clinical trial NCT02564328: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
Official title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Bone Marrow Mesenchymal Stem Cell
Transplantation
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2015-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Detailed description: Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. 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 ischemic stroke. The neurological outcome will be determined after transplantation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-80 chronic ischemia stroke or patients
* With stroke history of more than 6 months, less than 60 months
* NIHSS (NIH stroke scale) score of 7 or more points
* Internal carotid artery territory infarction measured by MRI
* Can be hospitalized and signed informed consent
* With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

* Lacunar infarction
* Recurrent thrombotic diseases less than 6 months
* Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
* Pregnant women
* Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
* Penicillin anaphylaxis or some other drugs allergy
* Autoimmune disease
* Inaccessibility for follow up

Primary outcomes:
measure: Change from baseline in Fugl-Meyer Scale at 12 months
timeFrame: 1,3,6 and 12 months
Secondary outcomes:
measure: Change from baseline in NIH Stroke Scale at 12 months
timeFrame: 1,3,6 and 12 months
measure: Change from baseline in Barthel Index at 12 months
timeFrame: 1,3,6 and 12 months
measure: Change from baseline in SSS at 12 months
timeFrame: 1,3,6 and 12 months
measure: Change from baseline in mRS at 12 months
timeFrame: 1,3,6 and 12 months
measure: Improvement of vision measured by brain visual examination
timeFrame: 1,6 and 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Xiaodan Jiang
state: Guangdong
Study officials:
affiliation: Southern Medical University
name: Xiaodan Jiang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: