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Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

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ClinicalTrials.gov Identifier: NCT01740908
Recruitment Status : Unknown
Verified November 2012 by Restorix Research Institute, LLLP.
Recruitment status was:  Enrolling by invitation
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborators:
Cytomedix
Island Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Changes in Peripheral Blood Population Numbers and Type. Other: Hyperbaric Oxygen Treatment

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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pilot Study for the Detection of Stem/Progenitor Cell Up-regulation Using Aldagen BRIGHT Technology in Peripheral Blood After Hyperbaric Oxygen Therapy (HBOT) Treatment
Study Start Date : December 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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 Name: 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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%)

Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740908


Locations
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United States, Washington
Restorix Wound Treatment Center at Island Hospital
Anacortes, Washington, United States, 98221
Sponsors and Collaborators
Restorix Research Institute, LLLP
Cytomedix
Island Hospital
Publications:
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Responsible Party: Restorix Research Institute, LLLP
ClinicalTrials.gov Identifier: NCT01740908    
Other Study ID Numbers: RRI-2012-05-STCELL-001
RF-STCELL-2012 ( Other Grant/Funding Number: Restorix Foundation/Cytomedix )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Keywords provided by Restorix Research Institute, LLLP:
hyperbaric oxygen
stem cell