Premature patients with bronchopulmonary dysplasia
Conditions
Brief summary
Safety assessment: adverse reactions (AR)
Detailed description
Status at week 36 EPM (death/DBP grade 3). Diagnosis and stage of BPD at 36 weeks EPM according to Jensen´s classification (no BPD, grade 1, grade 2 or grade 3). Exitus at 36 and 40 weeks of EPM or at discharge (yes/no). Incidence of comorbidities derived from prematurity. Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline. Variations in the modified respiratory score and RSS score during therapy and up to week 36 EPM.
Interventions
DRUGEXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS
Sponsors
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment: adverse reactions (AR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Status at week 36 EPM (death/DBP grade 3). Diagnosis and stage of BPD at 36 weeks EPM according to Jensen´s classification (no BPD, grade 1, grade 2 or grade 3). Exitus at 36 and 40 weeks of EPM or at discharge (yes/no). Incidence of comorbidities derived from prematurity. Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline. Variations in the modified respiratory score and RSS score during therapy and up to week 36 EPM. | — |
Countries
Spain
Outcome results
None listed