Using stem cells to treat lung disease in preterm newborns

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 trial investigates the use of allogeneic fetal mesenchymal stem cells from umbilical cord to reduce the incidence of bronchopulmonary dysplasia (BPD) in preterm newborns. The study will administer either three or six infusions of these stem cells to newborns who are on mechanical ventilation and at risk for developing BPD. The trial builds on previous Phase I findings that indicated the treatment is safe, with no reported adverse events. The goal is to determine not only the safety but also the feasibility and effectiveness of this intervention in preventing BPD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.

Exclusion Criteria:

* Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.
* Presence of refractory haemodynamic instability of any cause at the time of inclusion.
* Presence of severe neurological damage at the time of inclusion (HIV grade III or higher).
* Patients who have required major surgery in the 72 hours prior to inclusion.
* Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.
* Patients who are children of a mother with HIV

Where it's running

• Hospital Quironsalud Madrid
  Pozuelo de Alarcón, Madrid, Spain Recruiting
• Complejo Hospitalario La Coruña
  A Coruña, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Spain Recruiting
• Hospital Universitario La Paz
  Madrid, Spain Recruiting
• Hospital Universitario Carlos Haya
  Málaga, Spain Recruiting
• Hospital Vírgen del Rocío
  Seville, Spain Recruiting

Study contacts

• Principal investigator: María Jesús del Cerro, PhD — IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
• Study coordinator: María Jesús del Cerro, PhD
• Email: majecerro@yahoo.es
• Phone: 34 91 36 8000

Similar studies

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

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

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• 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.