NCT04811651CompletedPhase 2
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 156 (actual)
- First submitted
- 15 Mar 2021
- Start date
- 15 Mar 2021
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT04811651
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 156
- From 15 Mar 2021 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving intravenous thrombolysis;
Other illness
- Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
- 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);
- Patients with moderate to severe mental illness obviously interfere with treatment compliance;
Lab values
- 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;
Age
- Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
Other
- Patients who need or expect decompressive craniectomy;
- Patients who need or are expected to receive endovascular treatment ;
- Disturbance of consciousness；
- Posterior circulation cerebral infarction;
- Tumor patients;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.