Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Last updated: March 14, 2025
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Disease

Treatment

Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions

Control

Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions

Clinical Study ID

NCT06270199
PULMESCELL-2
  • Ages 1-28
  • All Genders

Study Summary

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanicalventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediateextubation foreseeable.

Exclusion

Exclusion Criteria:

  • Presence of another concomitant congenital pathology at the time of inclusion:pulmonary malformations with compromised pulmonary function, active pulmonaryhaemorrhage, severe pulmonary hypoplasia, renal malformations with systemiccompromise, congenital heart disease, polymalformative syndromes, chromosomopathies.

  • Presence of refractory haemodynamic instability of any cause at the time ofinclusion.

  • Presence of severe neurological damage at the time of inclusion (HIV grade III orhigher).

  • Patients who have required major surgery in the 72 hours prior to inclusion.

  • Patients who have necrotising enterocolitis (NEC) grades ≥II at the time ofinclusion, according to the Bell classification.

  • Patients who are children of a mother with HIV

Study Design

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Phase: 2
Study Start date:
January 11, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them).

In the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.

Connect with a study center

  • Hospital Quironsalud Madrid

    Pozuelo De Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • Complejo Hospitalario La Coruña

    La Coruña,
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Carlos Haya

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Vírgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.