Clinical trial NCT04811651: Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke
Official title: Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Stem Cell
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of modified Rankin Scale (mRS) 0-2
timeFrame: 90 Days
Secondary outcomes:
measure: Proportion of modified Rankin Scale (mRS) 0-2
timeFrame: 180，360 Days
measure: changes in Fugl-Meyer scale
timeFrame: 90days；180days；360days
measure: changes in Purdue hand function test
timeFrame: 90days；180days；360days
measure: changes in box and block test
timeFrame: 90days；180days；360days
measure: Proportion of modified Rankin Scale (mRS) 0-1
timeFrame: 90days；180days；360days
measure: changes in the national institutes of health stroke scale (NIHSS)
timeFrame: 90days；180days；360days
measure: changes in Mini-mental State Examination (MMSE) score
timeFrame: 90days；180days；360days
measure: changes in Montreal Cognitive Assessment (MoCA) score
timeFrame: 90days；180days；360days
measure: The changes of head images
timeFrame: 90days；180days；360days
measure: changes in some serum biomarkers
timeFrame: 90days；180days；360days
Other outcomes:
measure: Number of Adverse Events
timeFrame: 360days
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Chen Hui-Sheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: