Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

Completed · Not applicable

Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Hodgkins Lymphoma, Non-Hodgkins Lymphoma

In brief

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

Key facts

Study ID

NCT02099266

Run by

University of Kansas Medical Center

People needed

15

Starts

2013-06-01

Expected to finish

2016-02-01

Last updated by the study team

2017-06-12

Who can join

Age: 17 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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