Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

Phase 1

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Biological: Mesenchymal Stem Cell (MSC) therapy

• Registration Number: NCT02443961
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (\<1500 gr.) will develop BPD. The prevalence of BPD is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions. Methods: The investigators have designed a clinical trial to evaluate the feasibility and security of MSC therapy in patients at high risk of developing BPD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Study Start: 2019-04-02
• Primary Completion: 2020-04-02
• Study Completion: 2022-07-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Preterm newborns ≤ 28 weeks gestational age
• Birth Weight <1250 gr.
• Still on of mechanical ventilation FiO2 > 0,3 at day + 14

Exclusion Criteria

• Other congenital pathology (pulmonary malformations, active pulmonary bleeding, renal malformations, CHD, malformative syndromes, chromosomopathies)
• Severe neurological lesion.
• HIV infection
• Cardiovascular instability due to any cause
• 72 hours after mayor surgery
• Necrotizing enterocolitis grades II or higher, according to Bell classification, at the time of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem Cell (MSC) therapy	Mesenchymal Stem Cell (MSC) therapy	There will only be one treatment arm to evaluate the security of the treatment with MSC.

Primary Outcome Measures

Name	Time	Method
Feasibility and security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia (Number of participants with adverse events)	24 months	Number of participants with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Biomarker analysis (IL-1beta, IL-6, IP-10, INF-gamma, TGF beta, NLRP3, RAGE, HMGB1, VEGFA, GREMLIN1, sVEGFR1, IGF, ENDOTHELIN-1, SMPD-1, SP-D, SMPD3.	24 months	biomarkers will be measured in pg/ml
Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events)	24 months	Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)
Incidence of BPD and PH in very low birth weight babies treated with MSC	24 months	Diagnosed at 36 weeks of postmenstrual age

Trial Locations

Locations (4)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain