Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of subjects with Adverse Drug Reaction
研究概览
简要总结
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
详细描述
Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.
It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.
PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205)
排除标准
- •Infants whose parent or legal guardian did not want to participate in the study
结局指标
主要结局
Number of subjects with Adverse Drug Reaction
时间窗: at corrected age of 21 months (±3 months)
Blood test, chest x-ray, physical exam
次要结局
- Growth(Corrected gestational age of 4-6months, 8-12months, 18-24months)
- Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem®(at corrected age of 10 months (±2 months) and 21 months (±3 months))
研究者
Won Soon Park
Professor of Pediatrics
Samsung Medical Center