The Effect of Hyperbaric Oxygen Therapy on Circulating Hematopoietic Stem Cell Population
NCT ID: NCT06748586
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-30
2027-12-30
Brief Summary
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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 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Hyperbaric 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.
Interventions
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Hyperbaric 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
20 Years
80 Years
ALL
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Locations
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The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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Shai Efrati, Prof
Role: primary
Other Identifiers
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0165-24
Identifier Type: -
Identifier Source: org_study_id