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The Effect of Hyperbaric Oxygen Therapy on Circulating Hematopoietic Stem Cell Population

The Effect of Hyperbaric Oxygen Therapy (HBOT) on Circulating Hematopoietic Stem Cell Population , A Prospective Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06748586
Enrollment
60
Registered
2024-12-27
Start date
2025-03-05
Completion date
2027-12-30
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Hematopoietic Stem Cells

Keywords

hyperbaric oxygen therapy

Brief summary

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.

Interventions

DEVICEHyperbaric Oxygen Therapy

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. Investigational product: Multiplace hyperbaric oxygen chamber (Haux Starmed 2700, Germany) located at the Sagol center for hyperbaric medicine and research, Shamir (Assaf-Harofeh) Medical Center, Israel.

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

hyperbaric oxygen therapy (2ATA, 100% oxygen)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

1. Active or recent infection within the last month 2. Active malignancy. 3. History of hematopoietic disease 4. Low B12 or iron levels 5. Inability to sign the informed consent form 6. Leucocytes ˂4000 or ˃10,000

Design outcomes

Primary

MeasureTime frameDescription
hematopoietic stem cells evaluationChange from Baseline immediately after the interventionBlood 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.

Countries

Israel

Contacts

CONTACTShai Efrati, Prof
efratishai@outlook.com972549212866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026