A Phase 1 interventional study of Intravenous stem cell transplantation in Stroke, sponsored by Southern Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-30.
Sponsored by Southern Medical University, China · Phase 1, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Southern Medical University, China is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation
Genetic: Intravenous stem cell transplantation
Control group receive conventional stroke treatment that include rehabilitation
Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation
Change from baseline in Fugl-Meyer Scale at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in NIH Stroke Scale at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in SSS at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in mRS at 12 months
Time frame: 1,3,6 and 12 months
Improvement of vision measured by brain visual examination
Time frame: 1,6 and 12 months
The record gives a start of Nov 2014, a primary completion of Nov 2016 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Southern Medical University, China