Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

NCT01740908 | Unknown DMC

• 2 other identifiers: RRI-2012-05-STCELL-001RF-STCELL-2012
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Changes in Peripheral Blood Population Numbers and Type.

Keywords

hyperbaric oxygen; stem cell

Outcome Measures

Primary Outcomes (1)

• Peripheral blood analysis of circulating stem cells

  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.

  5 days

Study Arms (2)

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.

Other: Hyperbaric Oxygen Treatment

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.

Interventions

Hyperbaric Oxygen Treatment 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.

Also known as: 100% Oxygen USP

Hyperbaric Oxygen Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will reflect the racial and ethnic distribution that exists in the Anacortes metropolitan region. B- Skagit County, WA: White (91.4%), Black (0.9%), American Indian (2.6%), Asian or Pacific Islander (2.3%), Other (2.8%)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Restorix Research Institute, LLLP: lead
• Cytomedix: collaborator
• Island Hospital: collaborator

Study Sites (1)

Restorix Wound Treatment Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

Related Publications (1)

• 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.

  PMID: 16299259 BACKGROUND

MeSH Terms

Conditions

Limb-girdle muscular dystrophy, type 2C

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

US (1)