The Effect of Hyperbaric Oxygen Therapy (HBOT) on Circulating Hematopoietic Stem Cell Population , A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- hematopoietic stem cells evaluation
研究概览
简要总结
Hematopoietic stem cells (HSCs), which govern the production of all blood lineages, transition through a series of functional states characterized by expansion during fetal development, functional quiescence in adulthood, and decline upon aging.
Although research on aging has for a long time been relatively descriptive, much progress has been made in the past decade to uncover the molecular drivers of biological aging. One such drivers relates to stem cell exhaustion.
The amount and the function of HSCs decline in humans along aging. This decline is characterized by different changes such as signaling, epigenetic, cell surface markers etc. Various studies have been conducted to identify HSCs surface markers using flow cytometry.
Exposure to Hyperbaric Oxygen Therapy (HBOT) induce stem cells proliferation mobilization of stem progenitor cells (SPCs) in both animal and humans studies, and the number of SPCs remain elevated in blood over the course of 20 HBOT .
Additionally, Heyboer et al have found dose response curve between the HBOT protocol and circulating CD34+ and CD45-dim (stem cells potential markers): increasing the treatment pressure from 2.0 ATA to 2.5 ATA increased the concentration of circulating stem cells.
The aim of the current study is to evaluate the effect of HBOT on circulating hematopoietic stem cells, in the peripheral blood of patients who are candidate for HBOT.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study will include patients aged 20-80 who are intendent to start HBOT for other indication that are willing to give blood samples for measurements of circulating stem cells.
排除标准
- •Active or recent infection within the last month
- •Active malignancy.
- •History of hematopoietic disease
- •Low B12 or iron levels
- •Inability to sign the informed consent form
- •Leucocytes ˂4000 or ˃10,000
研究组 & 干预措施
Hyperbaric oxygen therapy (HBOT) active treatment
The HBOT protocol is 90 minutes, 5 times/week, for at least 40 sessions, 100% oxygen at 2 ATA with five-minute air breaks every 20 minutes
干预措施: Hyperbaric Oxygen Therapy (Device)
结局指标
主要结局
hematopoietic stem cells evaluation
时间窗: Change from Baseline immediately after the intervention
Blood test will be withdrawn for hematopoietic stem cells evaluation, CBC and chemistry. Evaluation of the hematopoietic stem cells population in PBMCs in different HBOT time points. Hematopoietic Stem cells will be identified by Flow cytometry immunostaining with the following markers: CD34, CD38- , CD45, CD45RA and CD90. A negative control will be an unstained tube and a tube containing CD45+CD34+ and CD38+, a positive control will be the Isotope control for each marker. The tube including the CD38- marker will be specific for the stem cells population.
次要结局
未报告次要终点
研究者
Shay Efrati
Prof.
Assaf-Harofeh Medical Center