NCT03739502

A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

Detailed 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.

Conditions

• AML
• NHL
• Hodgkin Disease
• All
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Hyperbaric oxygen	The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs). 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.

Timeline

• Start date: 2019-02-28
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2018-11-13
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study