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Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 30, 2012
First Posted Date December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2012)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments
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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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%)

Condition Changes in Peripheral Blood Population Numbers and Type.
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: 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.
Publications * 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. Epub 2005 Nov 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 30, 2012)
8
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01740908
Other Study ID Numbers RRI-2012-05-STCELL-001
RF-STCELL-2012 ( Other Grant/Funding Number: Restorix Foundation/Cytomedix )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Restorix Research Institute, LLLP
Study Sponsor Restorix Research Institute, LLLP
Collaborators
  • Cytomedix
  • Island Hospital
Investigators Not Provided
PRS Account Restorix Research Institute, LLLP
Verification Date November 2012