Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

November 30, 2012 updated by: Restorix Research Institute, LLLP

Pilot Study for the Detection of Stem/Progenitor Cell Up-regulation Using Aldagen BRIGHT Technology in Peripheral Blood After Hyperbaric Oxygen Therapy (HBOT) Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Anacortes, Washington, United States, 98221
        • Restorix Wound Treatment Center at Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / 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.
Other: 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.

Other Names:
  • 100% Oxygen USP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood analysis of circulating stem cells
Time Frame: 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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restorix Research Institute, LLLP

Collaborators

Cytomedix
Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RRI-2012-05-STCELL-001
  • RF-STCELL-2012 (Other Grant/Funding Number: Restorix Foundation/Cytomedix)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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