Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Placebo; Biological: Umbilical Cord-derived Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04811651

k（2019）46

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

intravenous umbilical cord derived mesenchymal stem cells

Treatment:

Biological: Umbilical Cord-derived Mesenchymal Stem Cells

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo