Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
A Pilot Study to Determine the Safety and Efficacy of Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
1 other identifier
interventional
15
1 country
1
Brief Summary
By doing this study, researchers hope to learn the following:
- If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process
- The safety of HBO administration in the setting of the UBC transplant
- The effects of HBO therapy on the engraftment process
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 17, 2017
CompletedJune 12, 2017
May 1, 2017
2.3 years
March 20, 2014
January 27, 2017
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
Toxicity assessment with 24hrs of treatment
Secondary Outcomes (2)
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Daily measurement of neutrophil counts up to 90 days post transplant.
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
28 days
Study Arms (1)
Hyperbaric Oxygen Treatment
EXPERIMENTALAdministration of hyperbaric oxygen the morning of UCB transplant.
Interventions
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Eligibility Criteria
You may qualify if:
- Voluntary written informed consent
- Subjects must be \>/= 17 yrs and \</= 70 yrs for non-myeloablative transplant
- Subjects must be \>/= 17 yrs and \</= 55 yrs for myeloablative transplant
- Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
- Use of approved form of contraception
- Karnofsky performance status of \>/= 70%
- Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
- ALT (alanine aminotransferase), AST (aspartate aminotransferase: \< 4x IULN (institutional upper limit of normal)
- Total bilirubin \</= 2 mg/dL
- Serum creatinine \< 2.0 mg/dL
- Left ventricular ejection fraction \>/= 45%
- FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin)
You may not qualify if:
- Pregnancy or breast feeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- History of seizures
- Claustrophobia
- Asthma
- Uncontrolled viral or bacterial infection at the time of enrollment
- Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
Aljitawi OS, Paul S, Ganguly A, Lin TL, Ganguly S, Vielhauer G, Capitano ML, Cantilena A, Lipe B, Mahnken JD, Wise A, Berry A, Singh AK, Shune L, Lominska C, Abhyankar S, Allin D, Laughlin M, McGuirk JP, Broxmeyer HE. Erythropoietin modulation is associated with improved homing and engraftment after umbilical cord blood transplantation. Blood. 2016 Dec 22;128(25):3000-3010. doi: 10.1182/blood-2016-05-715292. Epub 2016 Oct 19.
PMID: 27760758DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Omar Aljitawi
- Organization
- University of Kansas Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Aljitawi, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 28, 2014
Study Start
June 1, 2013
Primary Completion
October 1, 2015
Study Completion
February 1, 2016
Last Updated
June 12, 2017
Results First Posted
March 17, 2017
Record last verified: 2017-05