PHASE II CLINICAL TRIAL TO ESTABLISH THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- Safety assessment: adverse reactions (AR)
研究概览
简要总结
To evaluate the safety and feasibility of repeated intravenous infusions of UC-MSC 5*106 cells/kg in preterm patients ≤ 28 weeks gestational age and ≤ 1250g weight.
详细描述
Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them).
In the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Live newborns weighing ≤ 1250 grams and GA ≤ 28 weekswho are on invasive or noninvasive ventilatory support with an FiO2 ≥ 0.3 between days 5 and 14 of life,
排除标准
- •who have other concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies. - who present refractory hemodynamic instability of any cause at the time of inclusion. - who present severe neurological injury at the time of inclusion (HIV grade III or higher). - Who have required major surgery in the 72 hours prior to inclusion. - Who present necrotizing enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification. - who are children of a mother with HIV.
结局指标
主要结局
Safety assessment: adverse reactions (AR)
Safety assessment: adverse reactions (AR)
次要结局
- Status at week 36 EPM (death/DBP grade 3). Diagnosis and stage of BPD at 36 weeks EPM according to Jensen´s classification (no BPD, grade 1, grade 2 or grade 3). Exitus at 36 and 40 weeks of EPM or at discharge (yes/no). Incidence of comorbidities derived from prematurity. Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline. Variations in the modified respiratory score and RSS score during therapy and up to week 36 EPM.
研究者
Dr. María Jesús del Cerro
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal