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

May 9, 2017 updated by: University of Kansas Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen the morning of UCB transplant.
Device: Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other Names:
  • Monoplace Hyperbaric Chamber Model 3200 and 3200R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
Time Frame: Toxicity assessment with 24hrs of treatment
Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
Toxicity assessment with 24hrs of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Time Frame: Daily measurement of neutrophil counts up to 90 days post transplant.
Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.
Daily measurement of neutrophil counts up to 90 days post transplant.
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
Time Frame: 28 days
Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT-2011-08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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