Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
|ClinicalTrials.gov Identifier: NCT02099266|
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : March 17, 2017
Last Update Posted : June 12, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome (MDS) Hodgkins Lymphoma Non-Hodgkins Lymphoma||Device: Administration of hyperbaric oxygen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||February 2016|
Experimental: Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen the morning of UCB transplant.
Device: Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other Name: Monoplace Hyperbaric Chamber Model 3200 and 3200R
- Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation [ Time Frame: Toxicity assessment with 24hrs of treatment ]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.
- Determine the Effects of HBO Therapy on Neutrophil Count Recovery. [ Time Frame: Daily measurement of neutrophil counts up to 90 days post transplant. ]Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.
- Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment. [ Time Frame: 28 days ]Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099266
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Omar Aljitawi, MD||University of Kansas Medical Center|