Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers

Withdrawn before enrolling · Phase 2

Conditions studied: Bone Marrow Transplantation, Hematopoietic Stem Cells, Multiple Myeloma, Lymphoma

In brief

This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed for patients to undergo bone marrow transplantation and some patients fail to respond to current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other patient populations and we plan to investigate whether this intervention can act in concert with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone marrow transplantation. Twenty patients will be identified by participating hematologists who have failed to respond adequately to chemotherapy. When it is deemed appropriate to attempt an additional stem cell mobilization protocol, these patients will be administered chemotherapy as determined by their primary treating hematologist and additionally receive daily HBO2 (2.5 atmospheres absolute \[ATA\] for 90 minutes) for 3-8 days. At intervals, blood samples will be obtained as is the normal transplantation protocol practice to assess whether adequate stem cells are present in blood for the patient to proceed with transplantation. The project is anticipated to take one year to complete.

Key facts

Study ID

NCT02682953

Run by

University of Maryland, Baltimore

People needed

0

Starts

2015-10-01

Expected to finish

2017-08-01

Last updated by the study team

2019-12-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical indication for hematopoietic stem cell transplantation.
• Those failing to achieve an adequate collection of progenitor cells with standard chemotherapy treatment to safely perform hematopoietic stem cell transplantation.

You may not qualify if…

• Diabetes mellitus
• Renal or other organ transplantation and on immunosuppressive agents
• NYHA Class III or IV heart failure
• Liver cirrhosis
• HIV infection and/or AIDS
• Seizure disorder and not taking anti-seizure medications
• Asthma/bronchospasm not resolvable with inhaled bronchodilators
• Eustachian tube dysfunction and inability to equalization of pressure across the middle ears
• Confinement anxiety not controlled with oral benzodiazepine therapy.

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.