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Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

NCT02443961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-17

No results posted yet for this study

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

Interventions

BIOLOGICAL

Mesenchymal Stem Cell (MSC) therapy

3 doses of 5 million MSC will be administered

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar

    collaborator UNKNOWN

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Maria Jesus del Cerro, PhD · IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2020-04-02
Completion
2022-07-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443961 on ClinicalTrials.gov