Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739502
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2018-11-08
Brief Title:
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBO-UBC
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UBMT17044 | OTHER | Wilmot Cancer Institute | None |