INFORMATION ABOUT THE CLINICAL TRIAL

 

Introduction

 

Bronchopulmonary Dysplasia (BPD) is the most frequent disease as a result of premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop this disease. The prevalence of BPD is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. The etiology of BPD is multifactorial, in which oxigen, maternal corioamnionitis, insuficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension. Nowadays there is no efficient treatment, this generates an important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell Therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results.

 

Hypothesis

 

Repeated administration of allogeneic fetal mesenchymal stem cells from expanded umbilical cord is safe and can be performed in very low weight preterm newborns in order to reduce the incidence of severe BPD.

 

Objective

 

The main objective is to assess the feasibility and safety of therapy with allogenic fetal stem mesenchymal cells from expanded umbilical cord in premature patients with bronchopulmonary dysplasia.

 

Design

 

A phase II clinical trial has been designed to evaluate the safety of two different doses of therapy with allogeneic undifferentiated mesenchymal cells derived from umbilical cord as prevention and treatment of BPD in very low weight preterm newborns. We will compare its evolution with the control group to explore efficacy and evaluate the conduct of phase III studies. 75 patients will be recruited from all participating hospitals, who will be randomized to receive:

 

- Treatment with 3 infusions of 5 MSC 5x106 /kg body weight

 

- Treatment with 6 infusions of 5 MSC 5x106 /kg body weight

 

- Control group.

 

 

Patient entry criteria

- Inclusion criteria: Alive newborns with ≤ 1250g weight and GA≤ 28 weeks, who are in ventilatory support with FiO2≥ 0.3 between 5 and 14 days old, without immediate extubation planned.

 

- Exclusion Criteria:

1. Having another concomitant congenital pathology at the time of the inclusion: lung malformations with pulmonar involvement., active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic involvement, congenital heart disease, poly-malformation syndromes, chromosomal abnormalities.
2. Refractory hemodynamic instability from any cause at the time of inclusion.
3. Having any severe neurological injury at the time of inclusion (interventricular hemorrhage grades III or higher).
4. Major surgery 72 hours before the inclusion.
5. Necrotizing enterocolitis (grade II or higher according to Bell classification) at the time of inclusion.
6. Being born to an HIV-infected mother.

Promoter of PULMESCELL-2 Clinical Trial

 

Fundación de Investigación del Hospital Universitario Ramón y Cajal. Ctra Colmenar Viejo Km 9,100, 28034, Madrid.

 

Contact data

 

E-mail:

• pulmescell2@gmail.com

Phone:

• 913368825
• 913369027