Ischemic StrokePhase 2UMSISNCT04811651
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke
A Phase 2 study testing Umbilical Cord-derived Mesenchymal Stem Cells in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Umbilical Cord-derived Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
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
- Being tested
- Umbilical Cord-derived Mesenchymal Stem Cells, Placebo
- Keywords
- Ischemic Stroke, Stem Cell
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord-derived Mesenchymal Stem CellsBiological
umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.
PlaceboDrug
intravenous placebo solution with the same appearance as the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | intravenous umbilical cord derived mesenchymal stem cells Receives: Biological: Umbilical Cord-derived Mesenchymal Stem Cells |
| Placebo Comparator | Placebo comparator | intravenous placebo solution with the same appearance as the treatment group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 Days
Secondary outcomes (10)
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
Measured: 180，360 Days
changes in Fugl-Meyer scale
Fugl-Meyer Assessment Scale ranges from 0 to 100.
Measured: 90days；180days；360days
changes in Purdue hand function test
The changes of fine motor function were evaluated by Purdue hand function test
Measured: 90days；180days；360days
changes in box and block test
The changes of fine motor function were evaluated by box and block test
Measured: 90days；180days；360days
Proportion of modified Rankin Scale (mRS) 0-1
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS
Measured: 90days；180days；360days
changes in the national institutes of health stroke scale (NIHSS)
NIHSS ranges from 0-42, and high NIHSS means bad outcome
Measured: 90days；180days；360days
changes in Mini-mental State Examination (MMSE) score
MMSE score ranges from 0 to 30.
Measured: 90days；180days；360days
changes in Montreal Cognitive Assessment (MoCA) score
MOCA score ranges from 0 to 30.
Measured: 90days；180days；360days
The changes of head images
head images included flair, DTI
Measured: 90days；180days；360days
changes in some serum biomarkers
serum biomarkers included CPEC, VEGF, BDNF, MMP-9
Measured: 90days；180days；360days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start15 Mar 2021
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Chen Hui-Sheng, Doctor, Principal investigator, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811651
- Sponsor's protocol ID
- k（2019）46
- Acronym
- UMSIS
- Status last verified
- Sep 2024
- First submitted
- 15 Mar 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT04811651
- Acronym / sponsor ID
- UMSIS / k（2019）46
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Stem Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Umbilical Cord-derived Mesenchymal Stem Cellsintravenous umbilical cord derived mesenchymal stem cells |
| Placebo Comparator | Placebo comparator | Drug: Placebointravenous placebo solution with the same appearance as the treatment group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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）;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord-derived Mesenchymal Stem Cellsumbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million. | Biological | Treatment group |
| Placebointravenous placebo solution with the same appearance as the treatment group. | Drug | Placebo Comparator |
Primary outcome
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
10 secondary outcomes
Proportion of modified Rankin Scale (mRS) 0-2
Time frame: 180，360 Days
changes in Fugl-Meyer scale
Time frame: 90days；180days；360days
changes in Purdue hand function test
Time frame: 90days；180days；360days
changes in box and block test
Time frame: 90days；180days；360days
Proportion of modified Rankin Scale (mRS) 0-1
Time frame: 90days；180days；360days
changes in the national institutes of health stroke scale (NIHSS)
Time frame: 90days；180days；360days
changes in Mini-mental State Examination (MMSE) score
Time frame: 90days；180days；360days
changes in Montreal Cognitive Assessment (MoCA) score
Time frame: 90days；180days；360days
The changes of head images
Time frame: 90days；180days；360days
changes in some serum biomarkers
Time frame: 90days；180days；360days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Hui-Sheng, Doctor principal investigator
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical Cord-derived Mesenchymal Stem Cells in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of modified Rankin Scale (mRS) 0-2 (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.