Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 17 - 70 |
| Updated: | 3/16/2015 |
| Start Date: | June 2013 |
| End Date: | March 2016 |
| Contact: | Omar Aljitawi, MD |
| Email: | oaljitawi@kumc.edu |
| Phone: | 913-588-6029 |
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
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
- 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
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.
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.
Inclusion Criteria:
- Voluntary written informed consent
- Subjects must be >/= 17 yrs and
- Subjects must be >/= 17 yrs and
- 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
- 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
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