Changes in Peripheral Blood Population Numbers and Type.NCT01740908
Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments
An observational study of Changes in Peripheral Blood Population Numbers and Type., run by Restorix Research Institute, LLLP at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Peripheral Blood Population Numbers and Type.
- What is being tested?
- Hyperbaric Oxygen Treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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%)
Who may be able to join
- Patients recruited will be healthy volunteers with no current, ongoing infection or chronic disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Restorix Wound Treatment Center at Island Hospital
Anacortes, Washington, 98221
About this study
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
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.
- Being tested
- Hyperbaric Oxygen Treatment
- Keywords
- hyperbaric oxygen, stem cell
- Medical subject headings
- Limb-girdle muscular dystrophy, type 2C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TreatmentOther
Also called 100% Oxygen USP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Changes in Peripheral Blood Population Numbers and Type.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorix Research Institute, LLLP
- Sponsor type
- University, hospital or other
- Collaborators
- Cytomedix, Island Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740908
- Sponsor's protocol ID
- RRI-2012-05-STCELL-001
- Other IDs
- RF-STCELL-2012
- Status last verified
- Nov 2012
- First submitted
- 30 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1152/ajpheart.00888.2005. Epub 2005 Nov 18.
PubMed 16299259
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01740908
- Acronym / sponsor ID
- RRI-2012-05-STCELL-001
- Keywords
- hyperbaric oxygen, stem cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Restorix Research Institute, LLLPUniversity, hospital or other
- Collaborators
- Cytomedix, Island Hospital
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Treatment | – | Other: Hyperbaric Oxygen TreatmentSix 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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%)
Key inclusion criteria (1 listed)
- Patients recruited will be healthy volunteers with no current, ongoing infection or chronic disease.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TreatmentAlso: 100% Oxygen USPHyperabric 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 | Hyperbaric Oxygen Treatment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Background: PubMed 16299259Thom 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Changes in Peripheral Blood Population Numbers and Type., run by Restorix Research Institute, LLLP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood analysis of circulating stem cells (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.