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Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord-derived Mesenchymal Stem Cells
Placebo
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Stem Cell

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Placebo Comparator

Arm Description

intravenous umbilical cord derived mesenchymal stem cells

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
changes in Fugl-Meyer scale
Fugl-Meyer Assessment Scale ranges from 0 to 100.
changes in Purdue hand function test
The changes of fine motor function were evaluated by Purdue hand function test
changes in box and block test
The changes of fine motor function were evaluated by box and block test
Proportion of modified Rankin Scale (mRS) 0-1
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS
changes in the national institutes of health stroke scale (NIHSS)
NIHSS ranges from 0-42, and high NIHSS means bad outcome
changes in Mini-mental State Examination (MMSE) score
MMSE score ranges from 0 to 30.
changes in Montreal Cognitive Assessment (MoCA) score
MOCA score ranges from 0 to 30.
The changes of head images
head images included flair, DTI
changes in some serum biomarkers
serum biomarkers included CPEC, VEGF, BDNF, MMP-9

Full Information

First Posted
March 15, 2021
Last Updated
May 23, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT04811651
Brief Title
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke
Acronym
UMSIS
Official Title
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic Stroke, Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
intravenous umbilical cord derived mesenchymal stem cells
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
intravenous placebo solution with the same appearance as the treatment group.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord-derived Mesenchymal Stem Cells
Intervention Description
umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous placebo solution with the same appearance as the treatment group.
Primary Outcome Measure Information:
Title
Proportion of modified Rankin Scale (mRS) 0-2
Description
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Proportion of modified Rankin Scale (mRS) 0-2
Description
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time Frame
180,360 Days
Title
changes in Fugl-Meyer scale
Description
Fugl-Meyer Assessment Scale ranges from 0 to 100.
Time Frame
90days;180days;360days
Title
changes in Purdue hand function test
Description
The changes of fine motor function were evaluated by Purdue hand function test
Time Frame
90days;180days;360days
Title
changes in box and block test
Description
The changes of fine motor function were evaluated by box and block test
Time Frame
90days;180days;360days
Title
Proportion of modified Rankin Scale (mRS) 0-1
Description
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS
Time Frame
90days;180days;360days
Title
changes in the national institutes of health stroke scale (NIHSS)
Description
NIHSS ranges from 0-42, and high NIHSS means bad outcome
Time Frame
90days;180days;360days
Title
changes in Mini-mental State Examination (MMSE) score
Description
MMSE score ranges from 0 to 30.
Time Frame
90days;180days;360days
Title
changes in Montreal Cognitive Assessment (MoCA) score
Description
MOCA score ranges from 0 to 30.
Time Frame
90days;180days;360days
Title
The changes of head images
Description
head images included flair, DTI
Time Frame
90days;180days;360days
Title
changes in some serum biomarkers
Description
serum biomarkers included CPEC, VEGF, BDNF, MMP-9
Time Frame
90days;180days;360days
Other Pre-specified Outcome Measures:
Title
Number of Adverse Events
Time Frame
360days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hui-Sheng, Doctor
Phone
86-24-28897511
Ext
024-28897512
Email
chszh@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Xin-Hong, Doctor
Phone
86-15309885658
Email
450341972@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Hui-Sheng, Doctor
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, Ph.D.
Phone
+86 13352452086
Email
chszh@aliyun.com

12. IPD Sharing Statement

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Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

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