Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study

General Hospital of Shenyang Military Region1 site in 1 country200 target enrollmentMarch 15, 2021

ConditionsIschemic Stroke

InterventionsUmbilical Cord-derived Mesenchymal Stem Cells Placebo

DrugsUmbilical Cord-derived Mesenchymal Stem Cells Placebo

Overview

Phase: Phase 2
Intervention: Umbilical Cord-derived Mesenchymal Stem Cells
Conditions: Ischemic Stroke
Sponsor: General Hospital of Shenyang Military Region
Enrollment: 200
Locations: 1
Primary Endpoint: Proportion of modified Rankin Scale (mRS) 0-2
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.

Registry

clinicaltrials.gov

Start Date

March 15, 2021

End Date

June 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

General Hospital of Shenyang Military Region

Responsible Party

Principal Investigator

Hui-Sheng Chen

Director of neurology department

General Hospital of Shenyang Military Region

Eligibility Criteria

Inclusion Criteria

•Age: 18-80 years old;
•Patients with anterior circulation cerebral infarction;
•NIHSS: 6-25, and the limb movement score is at least 2 points;
•Hemoglobin \> 115g / L, platelet \> 100 × 109 / L, leukocyte \> 3 × 109 / L;
•the time from onset to treatment: group A（6-24 hours）、group B（1-3 days）、gourp C（4-7 days）、group D（1-4 weeks）、group E（1-6 months）;
•The patient or the legal representative of the patient can and is willing to sign the informed consent.

Exclusion Criteria

•Patients who need or expect decompressive craniectomy;
•Patients who need or are expected to receive endovascular treatment ;
•Patients receiving intravenous thrombolysis;
•Disturbance of consciousness；
•Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
•Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
•Posterior circulation cerebral infarction;
•Tumor patients;
•Epilepsy patients;
•Severe neurological deficit caused by stroke (MRS = 5);

Arms & Interventions

Treatment group

intravenous umbilical cord derived mesenchymal stem cells

Intervention: Umbilical Cord-derived Mesenchymal Stem Cells

Placebo Comparator

intravenous placebo solution with the same appearance as the treatment group.

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of modified Rankin Scale (mRS) 0-2

Time Frame: 90 Days

the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

Secondary Outcomes

Proportion of modified Rankin Scale (mRS) 0-2(180，360 Days)
changes in box and block test(90days；180days；360days)
Proportion of modified Rankin Scale (mRS) 0-1(90days；180days；360days)
changes in Montreal Cognitive Assessment (MoCA) score(90days；180days；360days)
The changes of head images(90days；180days；360days)
changes in Fugl-Meyer scale(90days；180days；360days)
changes in Purdue hand function test(90days；180days；360days)
changes in Mini-mental State Examination (MMSE) score(90days；180days；360days)
changes in the national institutes of health stroke scale (NIHSS)(90days；180days；360days)
changes in some serum biomarkers(90days；180days；360days)