A Phase 2 interventional study of Control and Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions in Bronchopulmonary Dysplasia, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Recruiting at 7 sites in Spain. Open to participants aged 1 Month to 28 Weeks. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Phase 2, Interventional, and Treatment
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.
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.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 75 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard cell therapy (control group)
Biological: Control
Treatment: three infusions of MSC 5x10\^6/Kg
Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Treatment: six infusions of MSC 5x10\^6/Kg
Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
Standard treatment
3 doses of 5 million MSC will be administered
6 doses of 5 million MSC will be administered
Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia
Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.
Time frame: 24 months
feasibility variable
Number of days of life from birth to administration of the first dose and number of days of life in successive doses.
Time frame: 24 months
Incidence of BPD and PH in very low birth weight babies treated with MSC
Status on week 36 of post-menstrual age
Time frame: 24 months
Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen
(No BPD/grade 1/grade 2/garde 3)
Time frame: 24 months
Exitus on week 36 and 40 of post-menstrual age or at hospital discharge
(Yes/No)
Time frame: 24 months
Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.
(sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage ≥ 2, retinopathy ≥ grade 2)
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).
biomarkers will be measured in pg/ml
Time frame: 24 months
Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy.
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%)
Time frame: 24 months
Changes in modified respirator score during therapy and up to week 36 of port-menstrual age
0 - 13 (min- max value). Higher score means worse outcome.
Time frame: 24 months
Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age
0-30 (min- max value). Higher score means worse outcome.
Time frame: 24 months
Date of hospital discharge and respiratory care at discharge.
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).
Number if patients that need supplemental O2
Time frame: 24 months
Duration of invasive and non-invasive mechanical ventilation.
Duration of invasive and non-invasive mechanical ventilation.
Time frame: 24 months
Use of postnatal corticosteroids indicated
For the treatment or prevention of BPD
Time frame: 24 months
Respiratory readmission rates.
During the first year
Time frame: 24 months
Bayley Neurodevelopmental Scale at 24 months
Evaluation of cognitive developement, languaje developement and motor developement.
Time frame: 24 months
Date and cause of death.
Date and cause of death.
Time frame: 24 months
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 19 phase 2 interventional studies under Bronchopulmonary Dysplasia, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 69. This study's planned 47 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Dec 2025 → Dec 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal