Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies
Overview
- Phase
- Phase 1
- Intervention
- Mesenchymal Stem Cell (MSC) therapy
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
Mesenchymal Stem Cell (MSC) therapy
There will only be one treatment arm to evaluate the security of the treatment with MSC.
Intervention: Mesenchymal Stem Cell (MSC) therapy
Outcomes
Primary Outcomes
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)
Time Frame: 24 months
Number of participants with adverse events as a measure of safety and tolerability
Secondary Outcomes
- 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.(24 months)
- Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events)(24 months)
- Incidence of BPD and PH in very low birth weight babies treated with MSC(24 months)