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

University of Kansas

Status: Completed

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

Treatments: Device: Administration of hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02099266

BMT-2011-08-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Hyperbaric Oxygen Treatment

Experimental group

Description:

Administration of hyperbaric oxygen the morning of UCB transplant.

Treatment:

Device: Administration of hyperbaric oxygen