Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

NCT04811651 | Completed Phase 2 DMC

• 1 other identifier: k（2019）46
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

Ischemic Stroke; Stem Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Proportion of modified Rankin Scale (mRS) 0-2

  180，360 Days

• changes in Fugl-Meyer scale

  90days；180days；360days

• changes in Purdue hand function test

  90days；180days；360days

• changes in box and block test

  90days；180days；360days

• Proportion of modified Rankin Scale (mRS) 0-1

  90days；180days；360days

Other Outcomes (1)

• Number of Adverse Events

  360days

Study Arms (2)

Treatment group

EXPERIMENTAL

intravenous umbilical cord derived mesenchymal stem cells

Biological: Umbilical Cord-derived Mesenchymal Stem Cells

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Umbilical Cord-derived Mesenchymal Stem Cells BIOLOGICAL

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

Treatment group

Placebo DRUG

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

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who need or expect decompressive craniectomy;
• Patients who need or are expected to receive endovascular treatment ;
• Patients receiving intravenous thrombolysis;
• Disturbance of consciousness；
• Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
• Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
• Posterior circulation cerebral infarction;
• Tumor patients;
• Epilepsy patients;
• Severe neurological deficit caused by stroke (MRS = 5);
• Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;
• Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (\< 100000 / mm3);
• 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;
• Patients with moderate to severe mental illness obviously interfere with treatment compliance;
• Patients with high blood pressure (systolic blood pressure \> 180mmhg) or low blood pressure (systolic blood pressure \< 90mmHg);

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chen Hui-Sheng, Doctor

  General Hospital of Shenyang Military Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurology department

Model Details: Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 23, 2021
• Study Start: March 15, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)