Acute Respiratory Distress SyndromePhase 1NCT04347967
Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)
A Phase 1 study testing UMC119-06 in people with Acute Respiratory Distress Syndrome, 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 moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- 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
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of age ≥ 20 years and ≤ 85 years.
- Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:
- No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
- Hypoxemia: PaO2/ FiO2 > 100 mmHg to ≤ 200 mmHg with PEEP ≥ 5 cm H2O.
- The time of onset of ARDS is when all of the specified ARDS criteria (2a-c) are met.
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- Patient is intubated and mechanically ventilated.
- Subjects who had an onset of ARDS within 72 to 120 hours before start of treatment.
- Subjects with body weight between 40 to 90 kg.
- No decompensated heart failure.
- Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.
- Women of child-bearing potential should have a negative serum 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 > 40 mIU/ml, OR;
- 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
Who cannot join
- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition.
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol.
- Expected life < 3 months from other cause than the respiratory failure.
- Subject is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support.
- Subjects with history of any type of malignancy.
- Major trauma in the prior 5 days.
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- 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 14 days.
- Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
- Subjects who have a significant concomitant illness as judged by principal investigator (PI).
- Subjects who have significant abnormal laboratory tests at screening:
- >5 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
- >3 × upper limit of normal for total bilirubin.
- >2 × upper limit of normal for serum creatinine.
- Subjects with known human immunodeficiency virus infection or who are immune compromised.
- Subjects who are unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
- Subjects with a history of severe allergic or anaphylactic reactions.
- Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
- Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, 23561
Claire Liao, +886-2-8978-7777 ext. 19965, Claire.Liao@meridigen.com
Joseph Chen, +886-2-8978-7777 ext. 19905, joseph.chen@meridigen.com
About this study
Official title: The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Respiratory Distress Syndrome (ARDS).
The clinical study with UMC119-06 is designed to investigate the safety in patients with moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.
Read the detailed description
ARDS, a noncardiogenic respiratory disease, is characterized by progressive hypoxemia and respiratory distress, associated with explosive acute inflammation and alveolar edema. ARDS occurs in all age group of patients, where mortality rates increase in advancing age.
In animal studies of ARDS, mensenchymal stem cells (MSCs) can attenuate lipopolysaccharides (LPS)-induced lung injury and pulmonary permeability edema through modulating the inflammatory. These findings show that MSCs may improve the clinical outcomes and prognosis of ARDS patient. Meridigen is developing UMC119-06, human umbilical cord-derived MSCs, for the treatment of ARDS. The purpose of this study is to assess the safety of UMC119-06 in patients with ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- UMC119-06
- Keywords
- ARDS
- Medical subject headings
- Respiratory Distress Syndrome
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 (7)
Changes in mortality status
Improvement in mortality status.
Measured: 15 months from the day of administration.
Ventilator Free Days (VFD)
Improvement in clinical function as assessed by Ventilator Free Days (VFD).
Measured: 28 days from the day of administration
Change in Oxygenation Index (OI)
Improvement in clinical function as assessed by change in Oxygenation Index (OI).
Measured: 7 days or discharge from ICU after the day of administration
Change in Lung Injury Score (LIS)
Improvement in clinical function as assessed by change in Lung Injury Score (LIS), 0-16 points, severity increasing with higher points.
Measured: 7 days or discharge from ICU after the day of administration
Change in positive end-expiratory pressure (PEEP)
Improvement in clinical function as assessed by change in positive end-expiratory pressure (PEEP).
Measured: 7 days or discharge from ICU after the day of administration
Change in Lung Static Compliance
Improvement in clinical function as assessed by change in Lung Static Compliance
Measured: 7 days or discharge from ICU after the day of administration
Change in acute physiology and chronic health evaluation score (APACHE II)
Improvement in clinical function as assessed by change in acute physiology and chronic health evaluation score (APACHE II), higher scores correspond to more severe disease and a higher risk of death.
Measured: 7 days 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 posted15 Apr 2020
- Study start1 Jan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 18 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
- NCT04347967
- Sponsor's protocol ID
- UMC119-06-ARDS-01
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2020
- 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 Respiratory Distress Syndrome (ARDS).
- ClinicalTrials.gov ID
- NCT04347967
- Acronym / sponsor ID
- UMC119-06-ARDS-01
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Meridigen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Apr 2020 (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 moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.
Detailed description
ARDS, a noncardiogenic respiratory disease, is characterized by progressive hypoxemia and respiratory distress, associated with explosive acute inflammation and alveolar edema. ARDS occurs in all age group of patients, where mortality rates increase in advancing age.
In animal studies of ARDS, mensenchymal stem cells (MSCs) can attenuate lipopolysaccharides (LPS)-induced lung injury and pulmonary permeability edema through modulating the inflammatory. These findings show that MSCs may improve the clinical outcomes and prognosis of ARDS patient. Meridigen is developing UMC119-06, human umbilical cord-derived MSCs, for the treatment of ARDS. The purpose of this study is to assess the safety of UMC119-06 in patients with ARDS.
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 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects of age ≥ 20 years and ≤ 85 years.
- Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:
- Patient is intubated and mechanically ventilated.
- Subjects who had an onset of ARDS within 72 to 120 hours before start of treatment.
- Subjects with body weight between 40 to 90 kg.
Key exclusion criteria (18 listed)
- Greater than 72 hours since first meeting ARDS criteria per the Berlin definition.
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol.
- Expected life < 3 months from other cause than the respiratory failure.
- Subject is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support.
- Subjects with history of any type of malignancy.
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.
7 secondary outcomes
Changes in mortality status
Time frame: 15 months from the day of administration.
Ventilator Free Days (VFD)
Time frame: 28 days from the day of administration
Change in Oxygenation Index (OI)
Time frame: 7 days or discharge from ICU after the day of administration
Change in Lung Injury Score (LIS)
Time frame: 7 days or discharge from ICU after the day of administration
Change in positive end-expiratory pressure (PEEP)
Time frame: 7 days or discharge from ICU after the day of administration
Change in Lung Static Compliance
Time frame: 7 days or discharge from ICU after the day of administration
Change in acute physiology and chronic health evaluation score (APACHE II)
Time frame: 7 days 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 Respiratory Distress Syndrome, 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 14 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: 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 (+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.