10 preterm babies under 28 weeks of gestational age and under 1250 grams of weight, at high risk of presenting pulmonary damage. MedDRA version: 20.0 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Células mesenquimales troncales fetales alogenicas de cordón umbilical expandidas
Product Code: Células mesenquimales troncales fetales alogenicas
Pharmaceutical Form: Solution for injec
Sponsors
Fundación para la investigación biomédica del Hospital Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Preterm newborns with a weight under or equal to 1250 gr and under 28 gestational age weeks, born between October 2017 and October 2018, that are candidates for corticoid therapy: - On mechanical ventilation with oxigen fraction of at least 0.3 con day 14th of life. - No prevision of extubation. Patients will be recluted in three different hospitals: Hospital La Paz, Hospital de Getafe, Hospital Clínico San Carlos and Hospital Puerta de Hierro. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Congenital malformation at the moment of inclusion: pulmonary malformations with decreased pulmonary function, pulmonary active bleeding, severe pulmonary hypoplasia, renal malformations with systemic afection, congenital heart disease, malformative syndromes, chromosomopathy. - Patients without a written consent. - Hemodynamic alterations at inclusio time. - Major surgery in the 72 previous hours before inclusion. - Necrotizing enterocolitis grades II or higher at inclusio time. - HIV infected mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the feasebility and security of mesenchymal stem cell therapy in preterm very low weight babies with high risk of developing bronchopulmonary dysplasia.;Secondary Objective: 1. Analysis of the changes of the inflammatory biomarkers after the administration of mesenchymal stem cell therapy. 2. Analysis of the variations of echocardiographic parameters related with the therapy. 3. Evaluation of the incidence of severe bronchopulmonary dysplasia and pulmonary hypertension y the group of treated patients.;Primary end point(s): Evaluation of the security of the therapy with mesenchymal stem cells in these patients.;Timepoint(s) of evaluation of this end point: At the end of the last doses the immediate effects will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the pulmonary development of these patients and the incidence of bronchopulmonary dysplasia.;Timepoint(s) of evaluation of this end point: These patients will be followed-up for 5 years, in order to evaluate the pulmonary system and the possible late adverse effects. | — |
Countries
Spain
Contacts
Public ContactDra. Álvarez Fuente
Fundación para la investigación biomédica del Hospital Ramón y Cajal.
Outcome results
None listed