Using stem cells to treat lung disease in preterm newborns
Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.
This study is testing if giving preterm newborns stem cells from umbilical cords can help prevent lung disease called bronchopulmonary dysplasia while they are on breathing machines.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 1 Month to 28 Weeks |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 7 sites (Pozuelo de Alarcón, Madrid and 6 other locations) |
| Trial ID | NCT06270199 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm newborns weighing 1250 grams or less and born at or before 28 weeks of gestation who require mechanical ventilation.
Not a fit: Patients with severe congenital conditions, significant neurological damage, or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the prevalence of bronchopulmonary dysplasia in vulnerable preterm infants.
How similar studies have performed: Previous studies have shown promising results with the use of mesenchymal stem cells in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pozuelo de Alarcón, Madrid and 6 other locations
- 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)
- Hospital Universitario y Politécnico La Fe — Valencia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.