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Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UMC119-06
Sponsored by
Meridigen Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects of age between ≥ 20 through ≤ 80 years.
  2. Subjects who had an onset of ischemic stroke within 48 to 168 hours before start of treatment.
  3. Subjects with occurrence of an ischemic stroke with clear motor or speech deficit documented by National Institutes of Health Stroke Scale (NIHSS) score of 5 to 20 (at the baseline assessment) that did not change by ≥4 points from the screening to the baseline assessment.
  4. Subjects who had an onset of ischemic stroke with large-artery atherosclerosis or cardioembolism.
  5. Subjects with confirmation of hemispheric cortical infarct with brain magnetic resonance imaging (MRI) including diffusion-weighted imaging demonstrating an acute lesion measuring <100 mL.
  6. Subjects modified Rankin score of 0 or 1, reported by subject or family, prior to the onset of symptoms of the current stroke.
  7. Subjects with body weight of 50 to 90 kgs.
  8. Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
  9. Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:

(1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy

Exclusion Criteria:

  1. Subjects with occurrence of a hemorrhagic transformation of ischemic stroke as evidenced by computerized tomography.
  2. Subjects with a lacunar a lesion of ≤ 1.5 cm of longest diameter or a brainstem infarct on MRI as the etiology of current stroke symptoms.
  3. Subjects with reduced level of consciousness (score of 3 for item 1a of NIHSS).
  4. Subjects who experienced seizures since the onset of ischemic stroke.
  5. Subjects with significant head trauma (GCS=3~8) or prior stroke within previous 3 months (except transient ischemic attack (TIA)).
  6. Subjects with uncontrolled hypertension despite antihypertensive treatments (persistent systolic blood pressure >180 mm Hg or diastolic >110 mm Hg).
  7. Subjects with blood glucose concentration <50 mg/dL or >400 mg/dL.
  8. Subjects with uncorrected coagulopathy including, but not limited to:

    1. International normalized ratio (INR) >1.4; or
    2. Activated partial thromboplastin time (aPTT) < 28sec or > 50sec ; or
    3. Platelet (PLT) count <100,000/ mm3 or > 700,000/ mm3.
  9. Subjects with history of any type of malignancy.
  10. Subjects with major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within previous 30 days.
  11. Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
  12. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:

    1. Severe kidney disease requiring hemodialysis or peritoneal dialysis; or
    2. Advanced liver disease such as liver cirrhosis; or
    3. Severe congestive heart failure (NYHA class 3 and 4); or
    4. Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and history of lung resection; or
    5. A known history of alcohol abuse or drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator; or
    6. A known history of severe allergic such as anaphylactic reactions; or
    7. A known history of allergy or hypersensitivity to any component of the formulation (normal saline and human serum albumin); or
    8. A known history of Alzheimer's disease or other dementias, Parkinson's disease, or any other neurological disorder that in the opinion of the trial doctor would affect their ability to participate in the trial or confound study assessments;
  13. Subjects who have the following conditions in laboratory tests;

    1. >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or
    2. >2 × ULN for serum creatinine;
  14. Subjects who are known to be infected with HIV.
  15. Subjects who cannot have CT or MRI test.
  16. Subjects unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
  17. Subjects who participated in another clinical study of new investigational therapies or has received an investigational therapy within 1 year before the study drug administration.
  18. Subjects who have the following medical history including:

    1. Autoimmune disease such as anti-phospholipid syndrome.
    2. Protein C deficiency.
    3. Protein S deficiency.
    4. Sickle cell anemia.
    5. Deep vein thrombosis.
    6. Pulmonary embolism
    7. Long-term use of oral contraceptive drug(defined as using oral contraceptive drug continuously more than 30 days)
    8. Controlled drug abuse.
    9. Brain vascular malformations such as moyamoya disease.

Sites / Locations

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UMC119-06

Arm Description

Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.

Outcomes

Primary Outcome Measures

The incidence and frequency of adverse events related to administration of UMC119-06.
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to AEs.

Secondary Outcome Measures

Changes in Modified Rankin Score (mRS)
Improvement in clinical function as assessed by change in Modified Rankin Score (mRS)
Changes in National Institute of Health Stroke Scale (NIHSS)
Improvement in clinical function as assessed by change in National Institute of Health Stroke Scale (NIHSS)
Changes in Barthel Index (BI)
Improvement in clinical function as assessed by change in Barthel Index (BI)
Changes in Brain MRI
Improvement in clinical function as assessed by change in Brain MRI

Full Information

First Posted
September 17, 2019
Last Updated
December 4, 2022
Sponsor
Meridigen Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04097652
Brief Title
Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke
Official Title
The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Ischemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridigen Biotech Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The clinical study with UMC119-06 is designed to investigate the safety in patients with acute ischemic stroke ("AIS"). This will be a dose escalation, open-label, single-center study in adult with acute ischemic stroke. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for treatment of acute ischemic stroke.
Detailed Description
Stroke is the second most important cause of mortality and morbidity in the world. Currently, the standard treatment for ischemic stroke is an intravenous tissue plasminogen activator(tPA; alteplase) and/or endovascular thrombectomy. However, the therapeutic time window for these treatments is narrow. Besides, endovascular thrombectomy requires specialized stroke expertise and endovascular skills. Less than 5% of ischemic stroke patients are treated by these therapy and not all patients achieve good outcomes. There is still a lack of therapy for the reduction disability from stroke. In 2018, at least 40 clinical trials intent to treat ischemic stroke using cell therapy. In particular, MSCs have shown great potential in the reduction disability from acute ischemic stroke (AIS). Meridigen is developing UMC119-06, a mesenchymal stem cell derived from human umbilical cord for the treatment of AIS disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
acute ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UMC119-06
Arm Type
Experimental
Arm Description
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Intervention Type
Biological
Intervention Name(s)
UMC119-06
Intervention Description
Cohort 1: Low does of UMC119-06;Cohort 2: Medium does of UMC119- 06;Cohort 3: High does of UMC119-06
Primary Outcome Measure Information:
Title
The incidence and frequency of adverse events related to administration of UMC119-06.
Description
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to AEs.
Time Frame
3 months from the day of administration
Secondary Outcome Measure Information:
Title
Changes in Modified Rankin Score (mRS)
Description
Improvement in clinical function as assessed by change in Modified Rankin Score (mRS)
Time Frame
15 months from the day of administration
Title
Changes in National Institute of Health Stroke Scale (NIHSS)
Description
Improvement in clinical function as assessed by change in National Institute of Health Stroke Scale (NIHSS)
Time Frame
15 months from the day of administration
Title
Changes in Barthel Index (BI)
Description
Improvement in clinical function as assessed by change in Barthel Index (BI)
Time Frame
15 months from the day of administration
Title
Changes in Brain MRI
Description
Improvement in clinical function as assessed by change in Brain MRI
Time Frame
15 months from the day of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects of age between ≥ 20 through ≤ 80 years. Subjects who had an onset of ischemic stroke within 48 to 168 hours before start of treatment. Subjects with occurrence of an ischemic stroke with clear motor or speech deficit documented by National Institutes of Health Stroke Scale (NIHSS) score of 5 to 20 (at the baseline assessment) that did not change by ≥4 points from the screening to the baseline assessment. Subjects who had an onset of ischemic stroke with large-artery atherosclerosis or cardioembolism. Subjects with confirmation of hemispheric cortical infarct with brain magnetic resonance imaging (MRI) including diffusion-weighted imaging demonstrating an acute lesion measuring <100 mL. Subjects modified Rankin score of 0 or 1, reported by subject or family, prior to the onset of symptoms of the current stroke. Subjects with body weight of 50 to 90 kgs. Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee. Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria: (1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy Exclusion Criteria: Subjects with occurrence of a hemorrhagic transformation of ischemic stroke as evidenced by computerized tomography. Subjects with a lacunar a lesion of ≤ 1.5 cm of longest diameter or a brainstem infarct on MRI as the etiology of current stroke symptoms. Subjects with reduced level of consciousness (score of 3 for item 1a of NIHSS). Subjects who experienced seizures since the onset of ischemic stroke. Subjects with significant head trauma (GCS=3~8) or prior stroke within previous 3 months (except transient ischemic attack (TIA)). Subjects with uncontrolled hypertension despite antihypertensive treatments (persistent systolic blood pressure >180 mm Hg or diastolic >110 mm Hg). Subjects with blood glucose concentration <50 mg/dL or >400 mg/dL. Subjects with uncorrected coagulopathy including, but not limited to: International normalized ratio (INR) >1.4; or Activated partial thromboplastin time (aPTT) < 28sec or > 50sec ; or Platelet (PLT) count <100,000/ mm3 or > 700,000/ mm3. Subjects with history of any type of malignancy. Subjects with major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within previous 30 days. Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to: Severe kidney disease requiring hemodialysis or peritoneal dialysis; or Advanced liver disease such as liver cirrhosis; or Severe congestive heart failure (NYHA class 3 and 4); or Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and history of lung resection; or A known history of alcohol abuse or drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator; or A known history of severe allergic such as anaphylactic reactions; or A known history of allergy or hypersensitivity to any component of the formulation (normal saline and human serum albumin); or A known history of Alzheimer's disease or other dementias, Parkinson's disease, or any other neurological disorder that in the opinion of the trial doctor would affect their ability to participate in the trial or confound study assessments; Subjects who have the following conditions in laboratory tests; >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or >2 × ULN for serum creatinine; Subjects who are known to be infected with HIV. Subjects who cannot have CT or MRI test. Subjects unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation. Subjects who participated in another clinical study of new investigational therapies or has received an investigational therapy within 1 year before the study drug administration. Subjects who have the following medical history including: Autoimmune disease such as anti-phospholipid syndrome. Protein C deficiency. Protein S deficiency. Sickle cell anemia. Deep vein thrombosis. Pulmonary embolism Long-term use of oral contraceptive drug(defined as using oral contraceptive drug continuously more than 30 days) Controlled drug abuse. Brain vascular malformations such as moyamoya disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandy Li, MS
Phone
+886-2-2627-5175
Ext
19933
Email
Mandy.Li@meridigen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Huang, MS
Phone
+886-2-2627-5175
Ext
19926
Email
Katherine.Huang@meridigen.com
Facility Information:
Facility Name
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Li, MS
Phone
+886-2-2627-5175
Ext
19933
Email
Mandy.Li@meridigen.com
First Name & Middle Initial & Last Name & Degree
Katherine Huang, MS
Phone
+886-2-2627-5175
Ext
19926
Email
Katherine.Huang@meridigen.com
First Name & Middle Initial & Last Name & Degree
Chaur-Jong Hu, M.D.
First Name & Middle Initial & Last Name & Degree
Lung Chan, M.D., Ph. D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke

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