PHASE II CLINICAL TRIAL TO ESTABLISH THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Enrollment
- 75
- Locations
- 7
- Primary Endpoint
- Safety assessment: adverse reactions (AR)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
To evaluate the safety and feasibility of repeated intravenous infusions of UC-MSC 5*106 cells/kg in preterm patients ≤ 28 weeks gestational age and ≤ 1250g weight.
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.
Investigators
Dr. María Jesús del Cerro
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
Eligibility Criteria
Inclusion Criteria
- •Live newborns weighing ≤ 1250 grams and GA ≤ 28 weekswho are on invasive or noninvasive ventilatory support with an FiO2 ≥ 0.3 between days 5 and 14 of life,
Exclusion Criteria
- •who have other concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies. - who present refractory hemodynamic instability of any cause at the time of inclusion. - who present severe neurological injury at the time of inclusion (HIV grade III or higher). - Who have required major surgery in the 72 hours prior to inclusion. - Who present necrotizing enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification. - who are children of a mother with HIV.
Outcomes
Primary Outcomes
Safety assessment: adverse reactions (AR)
Safety assessment: adverse reactions (AR)
Secondary Outcomes
- Status at week 36 EPM (death/DBP grade 3). Diagnosis and stage of BPD at 36 weeks EPM according to Jensen´s classification (no BPD, grade 1, grade 2 or grade 3). Exitus at 36 and 40 weeks of EPM or at discharge (yes/no). Incidence of comorbidities derived from prematurity. Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline. Variations in the modified respiratory score and RSS score during therapy and up to week 36 EPM.