Clinical trial · Interventional
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
A Pilot Study to Determine the Safety and Efficacy of Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
NCT02099266CI-TRIAL-00028078completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
By doing this study, researchers hope to learn the following: * If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process * The safety of HBO administration in the setting of the UBC transplant * The effects of HBO therapy on the engraftment process
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkins Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of hyperbaric oxygen | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperbaric Oxygen Treatment
- description
- Administration of hyperbaric oxygen the morning of UCB transplant.
- interventionNames
- Device: Administration of hyperbaric oxygen
Primary outcomes (1)
- measure
- Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
- timeFrame
- Toxicity assessment with 24hrs of treatment
- description
- Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.
Secondary outcomes (2)
- measure
- Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary written informed consent * Subjects must be \>/= 17 yrs and \</= 70 yrs for non-myeloablative transplant * Subjects must be \>/= 17 yrs and \</= 55 yrs for myeloablative transplant * Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant * Use of approved form of contraception * Karnofsky performance status of \>/= 70% * Adequate hepatic, renal, pulmonary and cardiac function. Criteria include: * ALT (alanine aminotransferase), AST (aspartate aminotransferase: \< 4x IULN (institutional upper limit of normal) * Total bilirubin \</= 2 mg/dL * Serum creatinine \< 2.0 mg/dL * Left ventricular ejection fraction \>/= 45% * FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin) Exclusion Criteria: * Pregnancy or breast feeding * Severe chronic obstructive pulmonary disease requiring oxygen supplementation * History of spontaneous pneumothorax * History of seizures * Claustrophobia * Asthma * Uncontrolled viral or bacterial infection at the time of enrollment * Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
References
Publications (1)
- DERIVEDAljitawi OS, Paul S, Ganguly A, Lin TL, Ganguly S, Vielhauer G, Capitano ML, Cantilena A, Lipe B, Mahnken JD, Wise A, Berry A, Singh AK, Shune L, Lominska C, Abhyankar S, Allin D, Laughlin M, McGuirk JP, Broxmeyer HE. Erythropoietin modulation is associated with improved homing and engraftment after umbilical cord blood transplantation. Blood. 2016 Dec 22;128(25):3000-3010. doi: 10.1182/blood-2016-05-715292. Epub 2016 Oct 19. PMID 27760758