Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

Phase 2

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Drug: Placebo; Biological: Umbilical Cord-derived Mesenchymal Stem Cells

• Registration Number: NCT04811651
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age: 18-80 years old;
2. Patients with anterior circulation cerebral infarction;
3. NIHSS: 6-25, and the limb movement score is at least 2 points;
4. Hemoglobin > 115g / L, platelet > 100 × 109 / L, leukocyte > 3 × 109 / L;
5. 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）;
6. The patient or the legal representative of the patient can and is willing to sign the informed consent.

Exclusion Criteria

1. Patients who need or expect decompressive craniectomy;
2. Patients who need or are expected to receive endovascular treatment ;
3. Patients receiving intravenous thrombolysis;
4. Disturbance of consciousness；
5. Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
6. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
7. Posterior circulation cerebral infarction;
8. Tumor patients;
9. Epilepsy patients;
10. Severe neurological deficit caused by stroke (MRS = 5);
11. Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;
12. Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (< 100000 / mm3);
13. Chronic liver disease, liver and kidney dysfunction, elevated ALT or ast (2 times higher than the upper limit of normal value), elevated serum creatinine (1.5 times higher than the upper limit of normal value) or dependent on renal dialysis;
14. Patients with moderate to severe mental illness obviously interfere with treatment compliance;
15. Patients with high blood pressure (systolic blood pressure > 180mmhg) or low blood pressure (systolic blood pressure < 90mmHg);
16. The expected survival time is less than one year;
17. Those who have conducted other trials within 3 months;
18. Other circumstances considered unsuitable by the researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo	intravenous placebo solution with the same appearance as the treatment group.
Treatment group	Umbilical Cord-derived Mesenchymal Stem Cells	intravenous umbilical cord derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Proportion of modified Rankin Scale (mRS) 0-2	90 Days	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Proportion of modified Rankin Scale (mRS) 0-2	180，360 Days	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
changes in box and block test	90days；180days；360days	The changes of fine motor function were evaluated by box and block test
Proportion of modified Rankin Scale (mRS) 0-1	90days；180days；360days	the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS
changes in Montreal Cognitive Assessment (MoCA) score	90days；180days；360days	MOCA score ranges from 0 to 30.
The changes of head images	90days；180days；360days	head images included flair, DTI
changes in Fugl-Meyer scale	90days；180days；360days	Fugl-Meyer Assessment Scale ranges from 0 to 100.
changes in Purdue hand function test	90days；180days；360days	The changes of fine motor function were evaluated by Purdue hand function test
changes in Mini-mental State Examination (MMSE) score	90days；180days；360days	MMSE score ranges from 0 to 30.
changes in the national institutes of health stroke scale (NIHSS)	90days；180days；360days	NIHSS ranges from 0-42, and high NIHSS means bad outcome
changes in some serum biomarkers	90days；180days；360days	serum biomarkers included CPEC, VEGF, BDNF, MMP-9

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China