Feaseability and security of the treatment of pulmonary disease in preterm babies with Mesenchymal Stem Cell Therapy.

Phase 1

• Conditions: 10 preterm babies under 28 weeks of gestational age and under 1250 grams of weight, at high risk of presenting pulmonary damage.; MedDRA version: 20.0Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003108-56-ES
• Lead Sponsor: Fundación para la investigación biomédica del Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-29
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified