Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
NCT ID: NCT06270199
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2024-01-11
2026-12-31
Brief Summary
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Detailed Description
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In the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Standard cell therapy (control group)
Control
Standard treatment
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Treatment: three infusions of MSC 5x10\^6/Kg
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
3 doses of 5 million MSC will be administered
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
Treatment: six infusions of MSC 5x10\^6/Kg
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
6 doses of 5 million MSC will be administered
Interventions
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Control
Standard treatment
Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
3 doses of 5 million MSC will be administered
Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
6 doses of 5 million MSC will be administered
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of refractory haemodynamic instability of any cause at the time of inclusion.
* Presence of severe neurological damage at the time of inclusion (HIV grade III or higher).
* Patients who have required major surgery in the 72 hours prior to inclusion.
* Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.
* Patients who are children of a mother with HIV
1 Month
28 Weeks
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Principal Investigators
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María Jesús del Cerro, PhD
Role: PRINCIPAL_INVESTIGATOR
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
Locations
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Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Complejo Hospitalario La Coruña
A Coruña, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Carlos Haya
Málaga, , Spain
Hospital Vírgen del Rocío
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Fernando Cabañas
Role: primary
Alejandro Dávila
Role: primary
Luis Arruza
Role: primary
Paloma Lopez
Role: primary
Tomás Sánchez Tamayo
Role: primary
Antonio Pavón Delgado
Role: primary
Máximo Vento
Role: primary
Other Identifiers
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PULMESCELL-2
Identifier Type: -
Identifier Source: org_study_id
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