Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

Ischemic Stroke Clinical Trial

— UMSIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811651
• Other study ID #: k(2019)46
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: General Hospital of Shenyang Military Region
• Contact: Chen Hui-Sheng, Doctor
• Phone: 86-24-28897511
• Email: chszh[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• Umbilical Cord-derived Mesenchymal Stem Cells
umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.

Drug:
• Placebo
intravenous placebo solution with the same appearance as the treatment group.

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

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