- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097652
Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke
The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Ischemic Stroke.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Claire Liao, MS
- Phone Number: 19965 +886-2-8978-7777
- Email: Claire.Liao@meridigen.com
Study Contact Backup
- Name: Joseph Chen, MS
- Phone Number: 19905 +886-2-8978-7777
- Email: joseph.chen@meridigen.com
Study Locations
-
-
-
New Taipei City, Taiwan, 23561
- Recruiting
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
-
Sub-Investigator:
- Lung Chan, M.D., Ph. D.
-
Contact:
- Claire Liao, MS
- Phone Number: 19965 +886-2-8978-7777
- Email: Claire.Liao@meridigen.com
-
Contact:
- Joesph Chen, MS
- Phone Number: 19905 +886-2-8978-7777
- Email: Joesph.chen@meridigen.com
-
Principal Investigator:
- Chaur-Jong Hu, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UMC119-06
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
|
Cohort 1: Low does of UMC119-06;Cohort 2: Medium does of UMC119- 06;Cohort 3: High does of UMC119-06
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence and frequency of adverse events related to administration of UMC119-06.
Time Frame: 3 months from the day of administration
|
|
3 months from the day of administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Modified Rankin Score (mRS)
Time Frame: 15 months from the day of administration
|
Improvement in clinical function as assessed by change in Modified Rankin Score (mRS)
|
15 months from the day of administration
|
Changes in National Institute of Health Stroke Scale (NIHSS)
Time Frame: 15 months from the day of administration
|
Improvement in clinical function as assessed by change in National Institute of Health Stroke Scale (NIHSS)
|
15 months from the day of administration
|
Changes in Barthel Index (BI)
Time Frame: 15 months from the day of administration
|
Improvement in clinical function as assessed by change in Barthel Index (BI)
|
15 months from the day of administration
|
Changes in Brain MRI
Time Frame: 15 months from the day of administration
|
Improvement in clinical function as assessed by change in Brain MRI
|
15 months from the day of administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMC119-06-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Ischemic Stroke
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Dongzhimen Hospital, BeijingThe Second Hospital of Hebei Medical University; Peking University Third Hospital and other collaboratorsRecruitingStroke, Ischemic | Stroke, Acute | Acute Ischemic StrokeChina
-
University of MiamiTemporarily not availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)CompletedAcute Ischemic Stroke (AIS)United States
-
Beijing Tiantan HospitalRecruitingIschemic Stroke, AcuteChina
-
Shanghai Yueyang Integrated Medicine HospitalRecruitingIschemic Stroke, AcuteChina
-
Beijing Tiantan HospitalCompletedIschemic Stroke, AcuteChina
-
Anaconda Biomed S.L.Not yet recruitingAcute Ischemic Stroke From Large Vessel Occlusion
-
Centre Hospitalier Sud FrancilienCompletedAcute Ischemic Stroke Due to Medium-vessel-occlusionFrance
Clinical Trials on UMC119-06
-
Meridigen Biotech Co., Ltd.Active, not recruitingChronic Obstructive Pulmonary Disease ModerateTaiwan
-
Meridigen Biotech Co., Ltd.Not yet recruitingAcute Respiratory Distress SyndromeTaiwan
-
Meridigen Biotech Co., Ltd.Recruiting
-
Meridigen Biotech Co., Ltd.Recruiting
-
NobelpharmaTerminatedNeuropathic Pain in CancerJapan
-
Nihon Pharmaceutical Co., LtdCompletedPortal Vein ThrombosisJapan
-
Peptinov SASRecruitingKnee OsteoarthritisFrance
-
Shanghai EpimAb Biotherapeutics Co., Ltd.RecruitingRelapsed or Refractory Multiple MyelomaChina, Australia
-
Dr. Reddy's Laboratories LimitedCompleted
-
Enovate Biolife Pvt LtdUnknown