A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation

Description:

However, UCB as a graft source for a bone marrow transplant has drawbacks related to the
limited cell dose available for transplant and defects in homing. Homing is the process of
UCB stem cell lodging in the bone marrow. If the homing is not efficient it could delay the
re-population of the stem cells (or engraftment), possibly lead to engraftment failure, and
delay the rebuilding of the immune system after transplant. This could, in turn, provide a
higher risk to infection after the UCB transplant.

This research study is aimed at investigating the use of hyperbaric oxygen (HBO) therapy
prior to the UCB transplant to find out if it will improve the stem cell homing, and
subsequently, the engraftment. HBO therapy involves breathing 100% pure oxygen while in a
sealed chamber that has been pressurized at 2 ½ times the normal atmospheric pressure.

There is a specific hormone which tells stem cells in the bone marrow to make more red blood
cells. This hormone (called EPO) is increased when blood oxygen levels are low. When the EPO
is increased, it might impair the bone marrow homing process of your transplant. Therefore,
the researchers conducting this study hope to determine if providing 100% pure oxygen to you
prior to your UCB transplant will decrease this hormone, and in turn, improve the homing
process after your transplant.

Condition:

AML

Treatment:

Hyperbaric oxygen

Start Date:

February 28, 2019

Sponsor:

University of Rochester

For More Information:

https://clinicaltrials.gov/show/NCT03739502