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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06270199
Other study ID # PULMESCELL-2
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 11, 2024
Est. completion date December 2026

Study information

Verified date February 2024
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact María Jesús del Cerro, PhD
Phone 34 91 36 8000
Email majecerro@yahoo.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 28 Weeks
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies. - 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
Spain Complejo Hospitalario La Coruña La Coruña
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Carlos Haya Málaga
Spain Hospital Vírgen del Rocío Sevilla
Spain Hospital Universitario y Politécnico La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Incidence of BPD and PH in very low birth weight babies treated with MSC Status on week 36 of post-menstrual age 24 months
Secondary Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen (No BPD/grade 1/grade 2/garde 3) 24 months
Secondary Exitus on week 36 and 40 of post-menstrual age or at hospital discharge (Yes/No) 24 months
Secondary Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. (sepsis confirmed by blood culture, treated patent ductus arteriosus, non-pharmacological ductal closure, necrotising enterocolitis, isolated bowel perforation, intraventricular haemorrhage = 2, retinopathy = grade 2) 24 months
Secondary 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). biomarkers will be measured in pg/ml 24 months
Secondary Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. NO PH (type I less 35%), MILD PH (type I-II between 35-50%) , MODERATE PH (type II between 50-70%) and SEVERE PH ( type II-III, more than 70%) 24 months
Secondary Changes in modified respirator score during therapy and up to week 36 of port-menstrual age 0 - 13 (min- max value). Higher score means worse outcome. 24 months
Secondary Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age 0-30 (min- max value). Higher score means worse outcome. 24 months
Secondary Date of hospital discharge and respiratory care at discharge. Date of hospital discharge and respiratory care at discharge. 24 months
Secondary Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). Number if patients that need supplemental O2 24 months
Secondary Duration of invasive and non-invasive mechanical ventilation. Duration of invasive and non-invasive mechanical ventilation. 24 months
Secondary Use of postnatal corticosteroids indicated For the treatment or prevention of BPD 24 months
Secondary Respiratory readmission rates. During the first year 24 months
Secondary Bayley Neurodevelopmental Scale at 24 months Evaluation of cognitive developement, languaje developement and motor developement. 24 months
Secondary Date and cause of death. Date and cause of death. 24 months
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