Skip to main content
OpenTrials
Completed

NCT Number: NCT04811651

Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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);
  • The expected survival time is less than one year;
  • Those who have conducted other trials within 3 months;
  • Other circumstances considered unsuitable by the researcher.

Treatment and study plan

Umbilical Cord-Derived Mesenchymal Stem Cells

Biological

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

Placebo

Drug

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

Primary outcomes

  1. Proportion of modified Rankin Scale (mRS) 0-2

    Time frame: 90 Days

    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

Secondary outcomes

  1. Proportion of modified Rankin Scale (mRS) 0-2

    Time frame: 180,360 Days

    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

  2. changes in Fugl-Meyer scale

    Time frame: 90days;180days;360days

    Fugl-Meyer Assessment Scale ranges from 0 to 100.

  3. changes in Purdue hand function test

    Time frame: 90days;180days;360days

    The changes of fine motor function were evaluated by Purdue hand function test

  4. changes in box and block test

    Time frame: 90days;180days;360days

    The changes of fine motor function were evaluated by box and block test

  5. Proportion of modified Rankin Scale (mRS) 0-1

    Time frame: 90days;180days;360days

    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS

  6. changes in the national institutes of health stroke scale (NIHSS)

    Time frame: 90days;180days;360days

    NIHSS ranges from 0-42, and high NIHSS means bad outcome

  7. changes in Mini-mental State Examination (MMSE) score

    Time frame: 90days;180days;360days

    MMSE score ranges from 0 to 30.

  8. changes in Montreal Cognitive Assessment (MoCA) score

    Time frame: 90days;180days;360days

    MOCA score ranges from 0 to 30.

  9. The changes of head images

    Time frame: 90days;180days;360days

    head images included flair, DTI

  10. changes in some serum biomarkers

    Time frame: 90days;180days;360days

    serum biomarkers included CPEC, VEGF, BDNF, MMP-9

Other outcomes

  1. Number of Adverse Events

    Time frame: 360days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Acronym: UMSIS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.