Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke

Phase 2

• Conditions: Stroke
• Interventions: Biological: Human umbilical cord mesenchymal stem cells

• Registration Number: NCT02580019
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-10-17
• Study First Posted: 2015-10-20
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Study Start: 2016-02
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
• Patients have received proper treatment within two weeks from the onset of stroke symptoms.
• Age between 18 to 70 years old for men or women
• Patients with persistent neurological deficit .
• Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
• Patients basic situation are allowable to be involved in the program.

Exclusion Criteria

• Patients with serious extensive stroke, who are unwilling to the risk.
• Patients with serious persistent neurological deficit (NIHSS > 24).
• Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
• Patients with serious psychological disease.
• Patients with myocardial infarction in recent 3 months.
• Patients with recurring thromboembolic disease in recentin recent 3 months.
• Patients with organ transplantation.
• Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
• Patients receive current immunosuppressive/immunomodulating treatment.
• Patients basic situation are unallowable to be involved in the program.
• Patients who refuse to participate.
• Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
• Patients who are pregnant or feeding women.
• Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hUC-MSC treatment	Human umbilical cord mesenchymal stem cells	Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation

Primary Outcome Measures

Name	Time	Method
Number of treatment related-adverse events during the study period.	180 days after transfusion

Secondary Outcome Measures

Name	Time	Method
Comparison of infarct size measured by brain MRI.	180 days after the cell treatment.
Comparison of modified Rankin scale (mRS).	180 days after the cell treatment.
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.	180 days after the cell treatment.
Comparison of National Institutes of Health stroke scale (NIHSS).	180 days after the cell treatment.

Trial Locations

Locations (1)

Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital); 🇨🇳 Beijing, Beijing, China