NCT02890953进行中（未招募）2 期
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Shunt or death
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVH grade 3-4
- •age : within postnatal day 28
- •gestational age: 23-<34 weeks
排除标准
- •Patient with severe congenital abnormalities
- •Patient with antenatal brain hemorrhage
- •Patient with asphyxia or Hypoxic ischemic encepalophathy
- •Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
- •Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
- •Patient withCRP > 30 mg/dL; Severe sepsis or shock
- •Patient with a history of participating in other clinical studies
- •Patient who is considered inappropriate to participate in the study by the investigator
研究组 & 干预措施
Control
Placebo Comparator
Control group receives placebo medication (normal saline)
干预措施: Normal saline (Drug)
MSC group
Experimental
MSC group receives mesenchymal stem cells transplantation (Pneumostem)
干预措施: Pneumostem (Drug)
结局指标
主要结局
Shunt or death
时间窗: 40 weeks of corrected age
Shunt operation or death
次要结局
- Death(at 2years)
- Developmental delay in gross motor function, 2y(at 2years)
- Developmental delay Bayley -3(at 2years)
- Developmental delay in KDST, 2y(at 2 years)
- Language delay(at 2 years, at 5 years)
- Developmental delay in KDST, 5y(at 5 years)
- Developmental delay in gross motor function, 5y(at 5years)
- Developmental delay in gross motor function(at 2years)
- epilepsy(at 2 years, at 5 years)
研究者
Won Soon Park
Professor
Samsung Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular HemorrhageMesenchymal Stromal CellsNCT02274428Samsung Medical Center9
Unknown
不适用
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular HemorrhageIntracranial HemorrhagesMesenchymal Stem CellsNewborn InfantNCT02673788Samsung Medical Center9
已完成
2 期
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature InfantsSevere Bronchopulmonary DysplasiaNCT03392467Medipost Co Ltd.60
尚未招募
不适用
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm InfantsRespiratory Distress Syndrome in Premature InfantNCT06229821Augusta University10
已完成
早期 1 期
Clinical Trial to Evaluate the Safety and Efficacy of EXG001-307 in Patients With Spinal Muscular Atrophy Type IType I Spinal Muscular AtrophyNCT06576388Hangzhou Jiayin Biotech Ltd2