Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Phase 2RecruitingNCT06270199

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchopulmonary Dysplasia

Interventions

ControlBIOLOGICAL

Standard treatment

Allogenic fetal mesenchymal stem cells from umbilical cord - three infusionsBIOLOGICAL

3 doses of 5 million MSC will be administered

Allogenic fetal mesenchymal stem cells from umbilical cord - six infusionsBIOLOGICAL

6 doses of 5 million MSC will be administered

Eligibility

Sex: ALLMin age: 1 MonthMax age: 28 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (7)

Hospital Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

RECRUITING

Complejo Hospitalario La Coruña

A Coruña, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Central Contacts

María Jesús del Cerro, PhD

CONTACT

34 91 36 8000 majecerro@yahoo.es

María Álvarez, MD

CONTACT

34 9 336 8000 mery1812@hotmail.com

Data from ClinicalTrials.gov

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