Clinical Trial to Stablish the Security of Using Allogeneic Fetal Stem Mesenchymal Cells From Umbilical Cord, Expanded in Pre-term Patients Suffering of Bronchopulmonary Dysplasia.
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 6 months
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Complejo Hospitalario La Coruña
RECRUITING
A Coruña
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Carlos Haya
RECRUITING
Málaga
Hospital Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Vírgen del Rocío
RECRUITING
Seville
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
María Jesús del Cerro, PhD
majecerro@yahoo.es
34 91 36 8000
Backup
María Álvarez, MD
mery1812@hotmail.com
34 9 336 8000
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 75
Treatments
Active_comparator: Control
Standard cell therapy (control group)
Experimental: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions
Treatment: three infusions of MSC 5x10\^6/Kg
Experimental: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
Treatment: six infusions of MSC 5x10\^6/Kg
Related Therapeutic Areas
Sponsors
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal