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Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

NCT ID: NCT01740908

Last Updated: 2012-12-04

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

UNKNOWN

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-01-31

Brief Summary

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This is an observational research study whose purposes are to see the effects of repeated hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than air at sea level. In this research, the concentration of oxygen will be twice the level of oxygen at sea level.

Detailed Description

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Conditions

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Changes in Peripheral Blood Population Numbers and Type.

Keywords

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hyperbaric oxygen stem cell

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperbaric Oxygen Treatment

Six healthy adult individuals (18-65 yrs), with no current, ongoing infection or chronic disease will be recruited for this study. Treatment study subjects will undergo a daily exposure to 2.0 ATA, 100% Oxygen for 90 minutes over 5 days.

Hyperbaric Oxygen Treatment

Intervention Type OTHER

Hyperabric oxygen will be delivered via a PerryPerry-Sigma Monoplace Hyperbaric Chambers. Oxygen is supplied by Air Gas, Seattle.

All gases will meet Health Standards for oxygen and air. The hyperbaric chamber technicians employed by Restorix Health are trained health personnel who will be assisting our study participant and monitoring the HBO treatment. Oxygen will be delivered at a pressure of 2.0 ATA for 90 minutes, once a day for 5 consective days.

Baseline

Two healthy study subjects with no current, ongoing infection or chronic disease will be rectuited to serve as a baseline group. Study subjects will not be exposed to HBO, but will have blood drawn at the same time as the treatment group.

No interventions assigned to this group

Interventions

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Hyperbaric Oxygen Treatment

Hyperabric oxygen will be delivered via a PerryPerry-Sigma Monoplace Hyperbaric Chambers. Oxygen is supplied by Air Gas, Seattle.

All gases will meet Health Standards for oxygen and air. The hyperbaric chamber technicians employed by Restorix Health are trained health personnel who will be assisting our study participant and monitoring the HBO treatment. Oxygen will be delivered at a pressure of 2.0 ATA for 90 minutes, once a day for 5 consective days.

Intervention Type OTHER

Other Intervention Names

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100% Oxygen USP

Eligibility Criteria

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Inclusion Criteria

Patients recruited will be healthy volunteers with no current, ongoing infection or chronic disease.

Exclusion Criteria

We will exclude or delay the treatment if our patients have an active lung infection, develops cancer, if the patient cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety. Any patient that cannot breathe without a respirator will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cytomedix

INDUSTRY

Sponsor Role collaborator

Island Hospital

OTHER

Sponsor Role collaborator

Restorix Research Institute, LLLP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Restorix Wound Treatment Center at Island Hospital

Anacortes, Washington, United States

Site Status

Countries

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United States

References

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Thom SR, Bhopale VM, Velazquez OC, Goldstein LJ, Thom LH, Buerk DG. Stem cell mobilization by hyperbaric oxygen. Am J Physiol Heart Circ Physiol. 2006 Apr;290(4):H1378-86. doi: 10.1152/ajpheart.00888.2005. Epub 2005 Nov 18.

Reference Type BACKGROUND
PMID: 16299259 (View on PubMed)

Other Identifiers

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RF-STCELL-2012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RRI-2012-05-STCELL-001

Identifier Type: -

Identifier Source: org_study_id