Clinical trial NCT02443961: Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies
Official title: Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia
pulmonary hypertension
stem cell therapy
mesenchymal stem cells
very low weight preterm babies
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundación de Ayuda a la Investigación sobre la Hipertensión pulmonar
First posted: 2015-05-14
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (\<1500 gr.) will develop BPD. 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 oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions. Methods: The investigators have designed a clinical trial to evaluate the feasibility and security of MSC therapy in patients at high risk of developing BPD.


Eligibility criteria: Inclusion Criteria:

* Preterm newborns ≤ 28 weeks gestational age
* Birth Weight \<1250 gr.
* Still on of mechanical ventilation FiO2 \> 0,3 at day + 14

Exclusion Criteria:

* Other congenital pathology (pulmonary malformations, active pulmonary bleeding, renal malformations, CHD, malformative syndromes, chromosomopathies)
* Severe neurological lesion.
* HIV infection
* Cardiovascular instability due to any cause
* 72 hours after mayor surgery
* Necrotizing enterocolitis grades II or higher, according to Bell classification, at the time of inclusion.

Primary outcomes:
measure: Feasibility and security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia (Number of participants with adverse events)
timeFrame: 24 months
Secondary outcomes:
measure: Biomarker analysis (IL-1beta, IL-6, IP-10, INF-gamma, TGF beta, NLRP3, RAGE, HMGB1, VEGFA, GREMLIN1, sVEGFR1, IGF, ENDOTHELIN-1, SMPD-1, SP-D, SMPD3.
timeFrame: 24 months
measure: Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events)
timeFrame: 24 months
measure: Incidence of BPD and PH in very low birth weight babies treated with MSC
timeFrame: 24 months
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: IRYCIS. Hospital Universitario Ramón y Cajal. Madrid. Spain
name: Maria Jesus del Cerro, PhD
role: PRINCIPAL_INVESTIGATOR
References: