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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270199
• Other study ID #: PULMESCELL-2
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

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