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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02099266
First Posted: March 28, 2014
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Kansas Medical Center
March 20, 2014
March 28, 2014
January 27, 2017
March 17, 2017
June 12, 2017
June 2013
October 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02099266 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Determine the Effects of HBO Therapy on Neutrophil Count Recovery. [ Time Frame: Daily measurement of neutrophil counts up to 90 days post transplant. ]
    Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.
  • Determine the effects of HBO therapy on engraftment [ Time Frame: Bone marrow chimerism testing at Day 21 or Day 28 ]
    The degree of engraftment will be determined through bone marrow chimerism assessments at either 21 or 28 days. Partial engraftment is defined as marrow reconstitution of 10-90% or donor cells and complete engraftment is defined as greater that 90% of donor cells.
Not Provided
  • To explore the effects of HBO therapy on inflammatory cytokines and EPO levels [ Time Frame: Blood sample collection Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. ]
    Determine if inflammatory cytokine and EPO levels are dropping after the HBO treatment
  • Determine the correlation between change in EPO levels and time to neutrophil recovery and engraftment. [ Time Frame: EPO measurements: Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. ]
    Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between EPO levels and subsequent engraftment and neutrophil recovery.
 
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
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
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome (MDS)
  • Hodgkins Lymphoma
  • Non-Hodgkins Lymphoma
Device: Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other Name: Monoplace Hyperbaric Chamber Model 3200 and 3200R
Experimental: Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen the morning of UCB transplant.
Intervention: Device: Administration of hyperbaric oxygen
Aljitawi OS, Paul S, Ganguly A, Lin TL, Ganguly S, Vielhauer G, Capitano ML, Cantilena A, Lipe B, Mahnken JD, Wise A, Berry A, Singh AK, Shune L, Lominska C, Abhyankar S, Allin D, Laughlin M, McGuirk JP, Broxmeyer HE. Erythropoietin modulation is associated with improved homing and engraftment after umbilical cord blood transplantation. Blood. 2016 Dec 22;128(25):3000-3010. doi: 10.1182/blood-2016-05-715292. Epub 2016 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
17 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02099266
BMT-2011-08-01
Yes
Not Provided
Not Provided
University of Kansas Medical Center
University of Kansas Medical Center
Not Provided
Principal Investigator: Omar Aljitawi, MD University of Kansas Medical Center
University of Kansas Medical Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP