Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

NCT ID: NCT04811651

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2024-07-30

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

intravenous umbilical cord derived mesenchymal stem cells

Group Type: EXPERIMENTAL

Umbilical Cord-derived Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.

Placebo Comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Umbilical Cord-derived Mesenchymal Stem Cells

umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Director of neurology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Hui-Sheng, Doctor

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Shenyang Military Region

Locations

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

k（2019）46

Identifier Type: -

Identifier Source: org_study_id