Effects of the Infusion of Autologous Non-cryopreserved CD34+ Cells in Newborns With Asphyxia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effects of Stem Cell Infusion at 1 week after discharge
研究概览
简要总结
The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.
详细描述
When there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. There is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites.
Cord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia.
There are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). We want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apgar < 5 at 5 minutes
- •Mixed or metabolic acidosis with a pH <7.0 from umbilical cord blood sample
- •Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy
- •Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)
排除标准
- •Neurodegenerative, autoimmune or genetic disease
- •Active infection at birth
- •Informed Consent not signed
结局指标
主要结局
Effects of Stem Cell Infusion at 1 week after discharge
时间窗: 1 week
Clinical assessment, including the Amiel-Tison Neurological Assessment
Effects of Stem Cell Infusion at 1 year after discharge
时间窗: 1 year
Clinical assessment, including the Amiel-Tison Neurological Assessment
次要结局
未报告次要终点
研究者
Consuelo Mancias Guerra
Pediatric Hematology Professor
Hospital Universitario Dr. Jose E. Gonzalez