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临床试验/NCT02443961
NCT02443961已完成1 期

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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
4
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
1 Week 至 28 Weeks(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Mesenchymal Stem Cell (MSC) therapy

Experimental

There will only be one treatment arm to evaluate the security of the treatment with MSC.

干预措施: Mesenchymal Stem Cell (MSC) therapy (Biological)

结局指标

主要结局

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)

时间窗: 24 months

Number of participants with adverse events as a measure of safety and tolerability

次要结局

  • 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)

研究者

研究点 (4)

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