Nicotinamide riboside supplementation to improve stem cell transplant outcomes
A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
This study is testing if taking nicotinamide riboside can help patients who receive a stem cell transplant recover faster and have fewer complications.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04332341 on ClinicalTrials.gov |
What this trial studies
This pilot feasibility study investigates the safety and tolerability of nicotinamide riboside (NR) supplementation in patients undergoing allogeneic hematopoietic cell transplantation (HCT). The study aims to determine if increasing NAD+ levels through NR can enhance engraftment, which is the process where transplanted stem cells grow in the bone marrow and produce new blood cells. By potentially shortening the time to engraftment, the study seeks to reduce the risks associated with prolonged recovery periods, such as the need for transfusions and antibiotics. Participants will receive NR supplementation and be monitored for neutrophil and platelet recovery post-transplant.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for allogeneic hematopoietic cell transplantation who meet specific eligibility criteria.
Not a fit: Patients with a history of allergy to NR compounds or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved health outcomes for patients undergoing stem cell transplants.
How similar studies have performed: While the approach of using nicotinamide riboside is relatively novel, preliminary studies suggest potential benefits in enhancing stem cell engraftment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All disease indications for allogeneic hematopoietic cell transplantation except for myelofibrosis. * Subject must meet program eligibility criteria\* for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning. * HLA-identical related donor or unrelated human donor source with bone marrow graft. * Subjects must provide a written informed consent. Exclusion Criteria: * History of allergy or intolerance to NR precursor compounds, including niacin or nicotinamide * Pregnant or breastfeeding women are excluded from this study since allogeneic HCT is a strict contraindication. * Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronald Sobecks, MD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Ronald Sobecks, MD
- Email: TaussigResearch@ccf.org
- Phone: 1-866-223-8100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.