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

NCT ID: NCT06748586

Last Updated: 2024-12-27

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2027-12-30

Brief Summary

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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

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Conditions

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Circulating Hematopoietic Stem Cells

Keywords

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hyperbaric oxygen therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

hyperbaric oxygen therapy (2ATA, 100% oxygen)
Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Shai Efrati, Prof

Role: CONTACT

Phone: 972549212866

Email: [email protected]

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