Study Stopped
subject recruitment not feasible due to standard care changes
Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed for patients to undergo bone marrow transplantation and some patients fail to respond to current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other patient populations and we plan to investigate whether this intervention can act in concert with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone marrow transplantation. Twenty patients will be identified by participating hematologists who have failed to respond adequately to chemotherapy. When it is deemed appropriate to attempt an additional stem cell mobilization protocol, these patients will be administered chemotherapy as determined by their primary treating hematologist and additionally receive daily HBO2 (2.5 atmospheres absolute \[ATA\] for 90 minutes) for 3-8 days. At intervals, blood samples will be obtained as is the normal transplantation protocol practice to assess whether adequate stem cells are present in blood for the patient to proceed with transplantation. The project is anticipated to take one year to complete.
Trial Health
Trial Health Score
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Started Oct 2015
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedDecember 11, 2019
December 1, 2019
1.3 years
February 9, 2016
December 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who adequately mobilize stem cells to undergo bone marrow transplantation.
Among entered patients, the number who adequately mobilization of stem cells to proceed with bone marrow transplantation
1-2 years
Study Arms (1)
Hyperbaric oxygen therapy
EXPERIMENTALExposure to oxygen at 2.4 atmospheres absolute for 90 minutes/day for 3 to 5 days
Interventions
Pharmacological agents often used for stem cell mobilization will be utilized in this study.
Exposure to oxygen at 2.4 atmospheres absolute for 90 minutes/day for 3 to 5 days
Pharmacological agents often used for stem cell mobilization will be utilized in this study.
Eligibility Criteria
You may qualify if:
- Clinical indication for hematopoietic stem cell transplantation.
- Those failing to achieve an adequate collection of progenitor cells with standard chemotherapy treatment to safely perform hematopoietic stem cell transplantation.
You may not qualify if:
- Diabetes mellitus
- Renal or other organ transplantation and on immunosuppressive agents
- NYHA Class III or IV heart failure
- Liver cirrhosis
- HIV infection and/or AIDS
- Seizure disorder and not taking anti-seizure medications
- Asthma/bronchospasm not resolvable with inhaled bronchodilators
- Eustachian tube dysfunction and inability to equalization of pressure across the middle ears
- Confinement anxiety not controlled with oral benzodiazepine therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- Healogicscollaborator
Study Sites (1)
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 17, 2016
Study Start
October 1, 2015
Primary Completion
February 1, 2017
Study Completion
August 1, 2017
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
Data on stem cell changes with treatment