Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

NCT02443961 | Completed Phase 1

• 1 other identifier: PULMESCEL-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary dysplasia; pulmonary hypertension; stem cell therapy; mesenchymal stem cells; very low weight preterm babies

Outcome Measures

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)

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

  24 months

Secondary Outcomes (3)

• 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

• 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

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

  24 months

Study Arms (1)

Mesenchymal Stem Cell (MSC) therapy

EXPERIMENTAL

There will only be one treatment arm to evaluate the security of the treatment with MSC.

Biological: Mesenchymal Stem Cell (MSC) therapy

Interventions

Mesenchymal Stem Cell (MSC) therapy BIOLOGICAL

3 doses of 5 million MSC will be administered

Mesenchymal Stem Cell (MSC) therapy

Eligibility Criteria

• Age: 1 Week - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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
• hours after mayor surgery

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Instituto de Salud Carlos III: collaborator
• Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar: collaborator

Study Sites (4)

Hospital Universitario A Coruña

A Coruña, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Hypertension, Pulmonary

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maria Jesus del Cerro, PhD

  IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 14, 2015
• Study Start: April 2, 2019
• Primary Completion: April 2, 2020
• Study Completion: July 7, 2022
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)