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Completed

NCT Number: NCT02443961

Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

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.

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Key information

Age range

1 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario A Coruña, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal Stem Cell (MSC) therapy

Biological

3 doses of 5 million MSC will be administered

Primary outcomes

  1. 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)

    Time frame: 24 months

    Number of participants with adverse events as a measure of safety and tolerability

Secondary outcomes

  1. 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.

    Time frame: 24 months

    biomarkers will be measured in pg/ml

  2. Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events)

    Time frame: 24 months

    Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)

  3. Incidence of BPD and PH in very low birth weight babies treated with MSC

    Time frame: 24 months

    Diagnosed at 36 weeks of postmenstrual age

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
  • Instituto de Salud Carlos III

Registry information

Official study title

Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
May 14, 2015
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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