Acute Ischemic StrokePhase 1NCT04097652
Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke
A Phase 1 study testing UMC119-06 in people with Acute Ischemic Stroke, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- UMC119-06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2019to 31 Dec 2025
- Phase
- Phase 1
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, 23561
Claire Liao, MS, +886-2-8978-7777 ext. 19965, Claire.Liao@meridigen.com
Joesph Chen, MS, +886-2-8978-7777 ext. 19905, Joesph.chen@meridigen.com
About this study
Official title: The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Ischemic Stroke.
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- UMC119-06
- Keywords
- acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMC119-06Biological
Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06
| Study group | Role | What they receive |
|---|---|---|
| UMC119-06 | Experimental | Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion. Receives: Biological: UMC119-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months from the day of administration
Secondary outcomes (4)
Changes in Modified Rankin Score (mRS)
Improvement in clinical function as assessed by change in Modified Rankin Score (mRS)
Measured: 15 months from the day of administration
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)
Measured: 15 months from the day of administration
Changes in Barthel Index (BI)
Improvement in clinical function as assessed by change in Barthel Index (BI)
Measured: 15 months from the day of administration
Changes in Brain MRI
Improvement in clinical function as assessed by change in Brain MRI
Measured: 15 months from the day of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start5 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meridigen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097652
- Sponsor's protocol ID
- UMC119-06-01
- Status last verified
- Dec 2022
- First submitted
- 17 Sep 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT04097652
- Acronym / sponsor ID
- UMC119-06-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Meridigen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UMC119-06 | Experimental | Biological: UMC119-06Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (40 listed)
- 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)).
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 |
|---|---|---|
| UMC119-06Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06 | Biological | UMC119-06 |
Primary outcome
The incidence and frequency of adverse events related to administration of UMC119-06.
Time frame: 3 months from the day of administration
* Incidence of Treatment-Emergent Adverse Events (TEAEs). * Incidence of withdrawals due to AEs.
4 secondary outcomes
Changes in Modified Rankin Score (mRS)
Time frame: 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
Changes in Barthel Index (BI)
Time frame: 15 months from the day of administration
Changes in Brain MRI
Time frame: 15 months from the day of administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UMC119-06 in people with Acute Ischemic Stroke, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.
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 10 inclusion and 40 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 Taiwan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Liao, MS (+886-2-8978-7777 ext. 19965, claire.liao@meridigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and frequency of adverse events related to administration of UMC119-06. (time frame: 3 months from the day of administration). 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 4 Dec 2023.