Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusionsBiological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusionsBiological: Control
- Registration Number
- NCT06270199
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions Treatment: six infusions of MSC 5x10\^6/Kg Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions Treatment: three infusions of MSC 5x10\^6/Kg Control Control Standard cell therapy (control group)
- Primary Outcome Measures
Name Time Method Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia 24 months Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
feasibility variable 24 months Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
- Secondary Outcome Measures
Name Time Method Duration of invasive and non-invasive mechanical ventilation. 24 months Duration of invasive and non-invasive mechanical ventilation.
Respiratory readmission rates. 24 months During the first year
Exitus on week 36 and 40 of post-menstrual age or at hospital discharge 24 months (Yes/No)
Incidence of BPD and PH in very low birth weight babies treated with MSC 24 months Status on week 36 of post-menstrual age
Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen 24 months (No BPD/grade 1/grade 2/garde 3)
Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. 24 months (sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage ≥ 2, retinopathy ≥ grade 2)
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). 24 months biomarkers will be measured in pg/ml
Changes in modified respirator score during therapy and up to week 36 of port-menstrual age 24 months 0 - 13 (min- max value). Higher score means worse outcome.
Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age 24 months 0-30 (min- max value). Higher score means worse outcome.
Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). 24 months Number if patients that need supplemental O2
Use of postnatal corticosteroids indicated 24 months For the treatment or prevention of BPD
Date and cause of death. 24 months Date and cause of death.
Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. 24 months NO PH (type I less 35%), MILD PH (type I-II between 35-50%) , MODERATE PH (type II between 50-70%) and SEVERE PH ( type II-III, more than 70%)
Date of hospital discharge and respiratory care at discharge. 24 months Date of hospital discharge and respiratory care at discharge.
Bayley Neurodevelopmental Scale at 24 months 24 months Evaluation of cognitive developement, languaje developement and motor developement.
Trial Locations
- Locations (7)
Hospital Quironsalud Madrid
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Complejo Hospitalario La Coruña
🇪🇸La Coruña, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Universitario Carlos Haya
🇪🇸Málaga, Spain
Hospital Vírgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain