Clinical Trial: Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Clinical Trial: Security and Feasibility of Mesenchymal Stem Cell Therapy in Treatment and Prevention of Bronchopulmonary Dysplasia in Preterm Babies

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.

Detailed Summary:
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. [ Time Frame: 24 months ]
    biomarkers will be measured in pg/ml
  • Changes in the echocardiographic parameters related with PH and preterm birth, in patients treated with MSC (Number of participants with echocardiographic adverse events) [ Time Frame: 24 months ]
    Flattening of the interventricular septum will be the main parameter (tipe I, I-II, II, II-III OR III)
  • Incidence of BPD and PH in very low birth weight babies treated with MSC [ Time Frame: 24 months ]
    Diagnosed at 36 weeks of postmenstrual age


Original Secondary Outcome: Same as current

Information By: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Dates:
Date Received: May 4, 2015
Date Started: May 2017
Date Completion: January 2019
Last Updated: February 16, 2017
Last Verified: February 2017