Hyperbaric oxygen effects on circulating blood-forming stem cells
The Effect of Hyperbaric Oxygen Therapy (HBOT) on Circulating Hematopoietic Stem Cell Population , A Prospective Study
This trial will try hyperbaric oxygen therapy to see if it increases circulating hematopoietic stem cells in adults aged 20–80 who are starting HBOT for another medical reason.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Zrifin) |
| Trial ID | NCT06748586 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults aged 20–80 who are intending to start hyperbaric oxygen therapy for a separate indication and agree to give blood samples. Participants will have serial blood draws before, during, and after a course of HBOT to measure circulating hematopoietic stem and progenitor cell populations using flow cytometry and related laboratory tests. People with active or recent infection, active malignancy, known hematopoietic disease, low B12 or iron, or abnormal leukocyte counts are excluded. The project aims to document whether HBOT sessions produce measurable increases in circulating HSCs and to characterize the timing of any changes.
Who should consider this trial
Good fit: Adults 20–80 years old who are about to start HBOT for another indication, have acceptable blood counts, and can provide informed consent and blood samples are the intended participants.
Not a fit: People with active or recent infections, active cancer, hematopoietic disorders, low B12 or iron, abnormal leukocyte counts, or inability to attend the study center are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, HBOT could be shown to temporarily raise circulating hematopoietic stem cell levels, suggesting a noninvasive way to boost or monitor stem cell availability in adults.
How similar studies have performed: Prior animal studies and small human reports have shown that hyperbaric oxygen can mobilize stem/progenitor cells and that counts may remain elevated over about 20 HBOT sessions, but larger clinical confirmation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zrifin
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) — Zrifin, Israel (Recruiting)
Study contacts
- Study coordinator: Shai Efrati, Prof
- Email: efratishai@outlook.com
- Phone: 972549212866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.