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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric Oxygen Treatment

Administration of hyperbaric oxygen the morning of UCB transplant.

Group Type EXPERIMENTAL

Administration of hyperbaric oxygen

Intervention Type DEVICE

Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Interventions

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Administration of hyperbaric oxygen

Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Intervention Type DEVICE

Other Intervention Names

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Monoplace Hyperbaric Chamber Model 3200 and 3200R

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No