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

Not Applicable

Not yet recruiting

• Conditions: Circulating Hematopoietic Stem Cells

• Registration Number: NCT06748586
• Lead Sponsor: Assaf-Harofeh Medical Center

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 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

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-03-30
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
hematopoietic stem cells evaluation	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.

Trial Locations

Locations (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh); 🇮🇱 Zrifin, Israel