Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

• Conditions: Changes in Peripheral Blood Population Numbers and Type.
• Interventions: Other: Hyperbaric Oxygen Treatment

• Registration Number: NCT01740908
• Lead Sponsor: Restorix Research Institute, LLLP

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Last Update Submitted: 2012-11-30
• Study Start: 2012-12
• Primary Completion: 2012-12
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Treatment	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.

Primary Outcome Measures

Name	Time	Method
Peripheral blood analysis of circulating stem cells	5 days	Six treatment subjects and two control subjects will have two daily blood draws. Exposures of hyperabric oxygen (HBO) will occur daily over 5 consecutive days. The blood draws will occur prior to starting HBO exposure and after finishing with the HBO exposure. Control subjects will have their blood drawn at the same time as the treatment subjects, in ordert to establish a non-treatment baseline. The stem cell population that is resident in the peripheral blood will be analyzed using the cell sorting and cell identification system at Aldagen. Mononulcear cells will be gated on the basis of forward and side laser light scatter, and 250,000 events will be analyzed to determine the percentage of ALDHbr cells, and the expression of additional stem cell markers, such as CD45, CD34, and CD105.

Trial Locations

Locations (1)

Restorix Wound Treatment Center at Island Hospital; 🇺🇸 Anacortes, Washington, United States