Using stem cells to prevent lung disease in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study investigates the safety of ex vivo cultured human umbilical cord-derived mesenchymal stem cells in infants at high risk for bronchopulmonary dysplasia (BPD). It is a dose escalation, open-label, single-center study conducted at National Chen-Kung University Hospital. The trial aims to determine the efficacy of this stem cell treatment in preventing BPD in neonatal infants who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Neonatal infants who fulfil all of the following criteria will be enrolled:

1. Subjects of postnatal age between 3 to 30 days.
2. 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.
3. Subjects with birth weight between 501g to 1249 g.
4. 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.
5. A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
6. A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
7. 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.

Exclusion Criteria:

Neonatal infants who meet any of the following criteria will be excluded:

1. Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
2. Have a known genetic syndrome.
3. Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
4. Have C-reactive protein (CRP) \>30 mg/L; or any infections including pneumonia, sepsis, or shock.
5. Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
6. Have active pulmonary hemorrhage or air leak syndrome.
7. 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).
8. Are known to be infected with HIV or CMV.
9. Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation.
10. Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation.
11. Are currently participating in any other interventional clinical trial.

Where it's running

• National Chen-Kung University Hospital
  Tainan, Taiwan Recruiting

Study contacts

• Study coordinator: Claire Liao, MS
• Email: claire.liao@meridigen.com
• Phone: +886-2-8978-7777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lung Ultrasound Score to predict BPD in very preterm babies

  This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.

  Recruiting at 4 sites Azienda USL Reggio Emilia - IRCCS · Modena and 3 other locations · NCT07633184

• Caffeine in pregnancy: how the mother and baby handle it during delivery

  This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT07570121

• IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier

  This trial will try intravenous immunoglobulin (IVIG) given over five days to see if it helps very preterm infants (≤28 weeks) who show early signs of bronchopulmonary dysplasia.

  Recruiting Phase 2 International Peace Maternity and Child Health Hospital · Shanghai · NCT07561125

• High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies

  This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.

  Recruiting Phase 1/2 University of Alabama at Birmingham · Birmingham, Alabama · NCT07307612

• Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies

  This tests whether giving smaller daily fluid volumes from day 8 of life (about 135 mL/kg/day) instead of larger volumes (about 165 mL/kg/day) lowers the chance of developing BPD or dying before 36 weeks in babies born before 30 weeks.

  Recruiting at 9 sites University Children's Hospital Basel · Aarau and 8 other locations · NCT06954142

• Using IVIG to treat bronchopulmonary dysplasia in premature infants

  This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.

  Recruiting Phase 2 International Peace Maternity and Child Health Hospital · Shanghai, Shanghai Municipality · NCT06925360

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.