Clinical trial NCT06270199: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Official title: Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia
Preterm newbnorn
Mesenchymal stem cells
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Group Assignment
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia
timeFrame: 24 months
measure: feasibility variable
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of BPD and PH in very low birth weight babies treated with MSC
timeFrame: 24 months
measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen
timeFrame: 24 months
measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge
timeFrame: 24 months
measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.
timeFrame: 24 months
measure: 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).
timeFrame: 24 months
measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy.
timeFrame: 24 months
measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age
timeFrame: 24 months
measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age
timeFrame: 24 months
measure: Date of hospital discharge and respiratory care at discharge.
timeFrame: 24 months
measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2).
timeFrame: 24 months
measure: Duration of invasive and non-invasive mechanical ventilation.
timeFrame: 24 months
measure: Use of postnatal corticosteroids indicated
timeFrame: 24 months
measure: Respiratory readmission rates.
timeFrame: 24 months
measure: Bayley Neurodevelopmental Scale at 24 months
timeFrame: 24 months
measure: Date and cause of death.
timeFrame: 24 months
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Quironsalud Madrid
state: Madrid
city: La Coruña
country: Spain
facility: Complejo Hospitalario La Coruña
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Vírgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
name: María Jesús del Cerro, PhD
role: PRINCIPAL_INVESTIGATOR
References: