The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.
Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).
- Human umbilical cord mesenchymal stem cells Biological
Intervention Desc: A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. ARM 1: Kind: Experimental Label: hUC-MSC treatment Description: Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number of treatment related-adverse events during the study period.||180 days after transfusion||Yes|
|Secondary||Comparison of National Institutes of Health stroke scale (NIHSS).||180 days after the cell treatment.||Yes|
|Secondary||Comparison of modified Rankin scale (mRS).||180 days after the cell treatment.||Yes|
|Secondary||Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.||180 days after the cell treatment.||Yes|
|Secondary||Comparison of infarct size measured by brain MRI.||180 days after the cell treatment.||Yes|