Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
This trial is active, not recruiting.
|Conditions||acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome (mds), hodgkins lymphoma, non-hodgkins lymphoma|
|Treatment||administration of hyperbaric oxygen|
|Sponsor||University of Kansas|
|Start date||June 2013|
|End date||September 2015|
|Trial size||15 participants|
|Trial identifier||NCT02099266, BMT-2011-08-01|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Administration of hyperbaric oxygen the morning of UCB transplant.
Safety of HBO administration in the setting of UCB stem cell transplantation
time frame: Toxicity assessment with 24hrs of treatment
Determine the effects of HBO therapy on neutrophil count recovery.
time frame: Daily measurement of neutrophil counts up to 90 days post transplant.
Determine the effects of HBO therapy on engraftment
time frame: Bone marrow chimerism testing at Day 21 or Day 28
Male or female participants from 17 years up to 70 years old.
Inclusion Criteria: - 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) Exclusion Criteria: - 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
|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|
|Principal investigator||Omar Aljitawi, MD|
|Description||Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.|
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