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
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).
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- 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