NCT02099266已完成不适用
A Pilot Study to Determine the Safety and Efficacy of Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
研究概览
简要总结
By doing this study, researchers hope to learn the following:
- If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process
- The safety of HBO administration in the setting of the UBC transplant
- The effects of HBO therapy on the engraftment process
详细描述
Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent
- •Subjects must be >/= 17 yrs and </= 70 yrs for non-myeloablative transplant
- •Subjects must be >/= 17 yrs and </= 55 yrs for myeloablative transplant
- •Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
- •Use of approved form of contraception
- •Karnofsky performance status of >/= 70%
- •Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
- •ALT (alanine aminotransferase), AST (aspartate aminotransferase: < 4x IULN (institutional upper limit of normal)
- •Total bilirubin </= 2 mg/dL
- •Serum creatinine < 2.0 mg/dL
- •Left ventricular ejection fraction >/= 45%
- •FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin)
排除标准
- •Pregnancy or breast feeding
- •Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- •History of spontaneous pneumothorax
- •History of seizures
- •Claustrophobia
- •Uncontrolled viral or bacterial infection at the time of enrollment
- •Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
结局指标
主要结局
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
时间窗: Toxicity assessment with 24hrs of treatment
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
次要结局
- Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.(28 days)
- Determine the Effects of HBO Therapy on Neutrophil Count Recovery.(Daily measurement of neutrophil counts up to 90 days post transplant.)
研究者
研究点 (2)
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