Study on Using Hyperbaric Oxygen to Improve Stem Cell Transplant from Umbilical Cord Blood

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03739502

Provider View

This clinical trial is exploring whether using hyperbaric oxygen therapy before a stem cell transplant from umbilical cord blood can help improve the process of the stem cells settling in the bone marrow, which is crucial for rebuilding the immune system after the transplant.

Patient Parameters

Program Overview

Umbilical cord blood (UCB) transplants are used to treat blood and lymph gland cancers. They have benefits like easy collection and lower risk of infections. However, they can have issues with the number of cells available and how well the cells settle in the bone marrow, which is important for the transplant to work. This study is testing if breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) before the transplant can help the stem cells settle better and improve the transplant's success.

Description

Umbilical cord blood (UCB) transplants are a type of stem cell transplant used to treat certain cancers. They are easier to obtain and have fewer risks compared to other transplants. However, they can have challenges, such as a limited number of cells and issues with the cells settling in the bone marrow, which is necessary for the transplant to succeed and for the immune system to recover.

This study is investigating whether using hyperbaric oxygen (HBO) therapy before the transplant can help improve the process. HBO therapy involves breathing 100% pure oxygen in a pressurized chamber. The idea is that this might help the stem cells settle better in the bone marrow, improving the transplant's success and reducing the risk of infection.

The study also looks at a hormone called EPO, which can affect how well the stem cells settle. By providing pure oxygen, researchers hope to lower this hormone and improve the transplant process.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Suitable for a stem cell transplant but lack a matched donor or cannot proceed with a donor transplant within 8 weeks.
  • Diagnosed with certain types of leukemia or lymphoma, or other specific blood disorders, and meet specific medical criteria.
  • Aged between 18 and 70 years.
  • Have a performance status score of 70% or higher, indicating good overall health.
  • Have adequate liver, kidney, heart, and lung function based on specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
  • Must be evaluated for fitness for hyperbaric oxygen therapy by a trained medical professional.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Severe lung disease requiring oxygen.
  • History of collapsed lung.
  • Active ear or sinus infections.
  • Recent chest surgery or radiation.
  • Claustrophobia.
  • Recent chemotherapy or radiation to the brain.
  • History of seizures.
  • Active tobacco use before and during the transplant process.

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