Bronchopulmonary DysplasiaPhase 1NCT03631420
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
A Phase 1 study testing Human Umbilical Cord Derived-Mesenchymal Stem Cells in people with Bronchopulmonary Dysplasia, run by Meridigen Biotech Co., Ltd. at 1 site in Taiwan.
Trial summary
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD. Read more about this study
- Who is it for?
- Ages 3 to 51 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2018to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 3 to 51 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonatal infants who fulfil all of the following criteria will be enrolled:
- Subjects of postnatal age between 3 to 30 days.
- Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks.
- Subjects with birth weight between 501g to 1249 g.
- Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study.
- A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
- A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
- Written informed consent has been provided by the subject's parents, legal guardians, or a legal representative, who agree to comply with all of the study procedures, including those in the long-term safety surveillance period.
Who cannot join
- Neonatal infants who meet any of the following criteria will be excluded:
- Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
- Have a known genetic syndrome.
- Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
- Have C-reactive protein (CRP) >30 mg/L; or any infections including pneumonia, sepsis, or shock.
- Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
Show all 12Show fewer
- Have active pulmonary hemorrhage or air leak syndrome.
- Have abnormal hepatic (AST, ALT >150 U/L or direct bilirubin >2 mg/dL or total bilirubin >15 mg/dL) or renal function (serum creatinine >1 mg/dL or oliguria).
- Are known to be infected with HIV or CMV.
- Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation.
- Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation.
- Are currently participating in any other interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Chen-Kung University Hospital
Tainan
Claire Liao, MS, +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 Feasibility of UMC119-01 Cell Therapy in Infants at High Risk for Bronchopulmonary Dysplasia
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
Read the detailed description
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord Derived-Mesenchymal Stem CellsBiological
Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg
| Study group | Role | What they receive |
|---|---|---|
| UMC119-01 | Experimental | UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product Receives: Biological: Human Umbilical Cord Derived-Mesenchymal Stem Cells |
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 UMC119-01.
- The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01.
Measured: 3 months from the day of administration
Secondary outcomes (7)
The percentage of subjects who died from any cause during the study.
The percentage of subjects who died from any cause during the study.
Measured: 3 months from the day of administration
Changes of the oxygen saturation.
Changes from baseline of the oxygen saturation.
Measured: 3 months from the day of administration
Changes of chest x-ray findings in participants before and after administration.
Changes from baseline to 3 months of chest x-ray findings in participants before and after administration.
Measured: 3 months from the day of administration
Changes of inflammatory markers (pg/ml) before and after administration.
Changes from baseline of inflammatory markers (pg/ml) .
Measured: 3 days and 7 days after administration
Comparison of the incidence and severity of preterm children's complications in participants before and after administration.
Comparison of the incidence and severity of preterm children's complications in participants before and after administration.
Measured: 3 months from the day of administration
The number of days of intubation, or where ventilator or oxygen therapy.
The number of days of intubation, or where ventilator or oxygen therapy.
Measured: 3 months from the day of administration
Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).
Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).
Measured: 36 weeks postmenstrual age (PMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start26 Oct 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Prevention
- 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
- NCT03631420
- Sponsor's protocol ID
- UMC119-01-001
- Status last verified
- Dec 2022
- First submitted
- 9 Apr 2018
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Feasibility of UMC119-01 Cell Therapy in Infants at High Risk for Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT03631420
- Acronym / sponsor ID
- UMC119-01-001
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Meridigen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Aug 2018 (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 UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
Detailed description
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UMC119-01 | Experimental | Biological: Human Umbilical Cord Derived-Mesenchymal Stem CellsUMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product |
Who may qualify
- Ages
- 3 to 51 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects of postnatal age between 3 to 30 days.
- Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks.
- Subjects with birth weight between 501g to 1249 g.
- Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study.
- A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
Key exclusion criteria (12 listed)
- Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
- Have a known genetic syndrome.
- Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
- Have C-reactive protein (CRP) >30 mg/L; or any infections including pneumonia, sepsis, or shock.
- Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
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 |
|---|---|---|
| Human Umbilical Cord Derived-Mesenchymal Stem CellsCohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg | Biological | UMC119-01 |
Primary outcome
The incidence and frequency of adverse events related to administration of UMC119-01.
Time frame: 3 months from the day of administration
• The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01.
7 secondary outcomes
The percentage of subjects who died from any cause during the study.
Time frame: 3 months from the day of administration
Changes of the oxygen saturation.
Time frame: 3 months from the day of administration
Changes of chest x-ray findings in participants before and after administration.
Time frame: 3 months from the day of administration
Changes of inflammatory markers (pg/ml) before and after administration.
Time frame: 3 days and 7 days after administration
Comparison of the incidence and severity of preterm children's complications in participants before and after administration.
Time frame: 3 months from the day of administration
The number of days of intubation, or where ventilator or oxygen therapy.
Time frame: 3 months from the day of administration
Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).
Time frame: 36 weeks postmenstrual age (PMA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
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 Human Umbilical Cord Derived-Mesenchymal Stem Cells in people with Bronchopulmonary Dysplasia, 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 8 inclusion and 12 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
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 UMC119-01. (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.