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

Official title

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.

Overview

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.

Detailed 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.

Interventions

• Biological Control
  Standard treatment
• Biological Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
  3 doses of 5 million MSC will be administered
• Biological Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
  6 doses of 5 million MSC will be administered

Primary outcome measures

• Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia [Time frame: 24 months]
• feasibility variable [Time frame: 24 months]

Secondary outcome measures (12)

• Incidence of BPD and PH in very low birth weight babies treated with MSC [Time frame: 24 months]
• Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen [Time frame: 24 months]
• Exitus on week 36 and 40 of post-menstrual age or at hospital discharge [Time frame: 24 months]
• Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. [Time frame: 24 months]
• Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). [Time frame: 24 months]
• Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. [Time frame: 24 months]
• Changes in modified respirator score during therapy and up to week 36 of port-menstrual age [Time frame: 24 months]
• Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age [Time frame: 24 months]
• Date of hospital discharge and respiratory care at discharge. [Time frame: 24 months]
• Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). [Time frame: 24 months]
• Duration of invasive and non-invasive mechanical ventilation. [Time frame: 24 months]
• Use of postnatal corticosteroids indicated [Time frame: 24 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 7 centers

• Hospital Quironsalud Madrid — Pozuelo de Alarcón
• Complejo Hospitalario La Coruña — A Coruña
• Hospital Clínico San Carlos — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Carlos Haya — Málaga
• Hospital Vírgen del Rocío — Seville
• Hospital Universitario y Politécnico La Fe — Valencia

Identifiers

NCT: NCT06270199 · PULMESCELL-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗