NCT06270199

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 11, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

January 16, 2024

Last Update Submit

March 14, 2025

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary dysplasiaPreterm newbnornMesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia

    Number of patients with adverse events during the infusion time and during all study; and comorbilities due to preterm birth.

    24 months

  • feasibility variable

    Number of days of life from birth to administration of the first dose and number of days of life in successive doses.

    24 months

Secondary Outcomes (15)

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

    24 months

  • Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen

    24 months

  • Exitus on week 36 and 40 of post-menstrual age or at hospital discharge

    24 months

  • Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death.

    24 months

  • 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).

    24 months

  • +10 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

Standard cell therapy (control group)

Biological: Control

Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions

EXPERIMENTAL

Treatment: three infusions of MSC 5x10\^6/Kg

Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions

Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions

EXPERIMENTAL

Treatment: six infusions of MSC 5x10\^6/Kg

Biological: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions

Interventions

ControlBIOLOGICAL

Standard treatment

Control
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusionsBIOLOGICAL

3 doses of 5 million MSC will be administered

Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusionsBIOLOGICAL

6 doses of 5 million MSC will be administered

Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions

Eligibility Criteria

Age1 Month - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are children of a mother with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Complejo Hospitalario La Coruña

A Coruña, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Carlos Haya

Málaga, Spain

RECRUITING

Hospital Vírgen del Rocío

Seville, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • María Jesús del Cerro, PhD

    IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Jesús del Cerro, PhD

CONTACT

34 91 36 8000majecerro@yahoo.es

María Álvarez, MD

CONTACT

34 9 336 8000mery1812@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2024

First Posted

February 21, 2024

Study Start

January 11, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

ES(7)