NCT06270199

Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 1 Month – 28 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them). 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

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Control	Standard treatment
BIOLOGICAL	Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions	3 doses of 5 million MSC will be administered
BIOLOGICAL	Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions	6 doses of 5 million MSC will be administered

Timeline

• Start date: 2024-01-11
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-02-21
• Last updated: 2025-03-17

Locations

7 sites across 1 country: Spain