20 Participants Needed

NR Supplementation for Bone Marrow Transplant Engraftment Improvement

RS
Overseen ByRonald Sobecks, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a safe method to enhance recovery after a bone marrow transplant. Researchers are testing whether adding nicotinamide riboside, a vitamin B supplement, to donor cells can increase blood stem cell numbers and accelerate recovery. The trial seeks participants planning to undergo a specific type of bone marrow transplant with a matching human donor. Individuals with certain allergies or conditions that might interfere with the trial requirements are not suitable for this study. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that nicotinamide riboside is likely to be safe for humans?

Research has shown that nicotinamide riboside (NR), a type of vitamin B3, is generally safe. Some studies indicate that NR is as safe as nicotinamide, another form of vitamin B3. Even in high amounts, the main concerns involve effects on the liver and kidneys, but these effects were not serious.

NR is also sold as a dietary supplement, suggesting it is safe for most people. However, this study is in an early stage, so researchers are still carefully monitoring its safety. While NR appears promising, participants should know it is still under testing, and any potential risks are being closely observed.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Nicotinamide Riboside (NR) because it offers a fresh approach to improving bone marrow transplant engraftment. Unlike traditional treatments that focus on immune suppression or support, NR works by boosting cellular energy and enhancing cell repair through a unique mechanism that increases NAD+ levels, a vital molecule for cell function and resilience. This could potentially lead to faster and more effective engraftment, providing a significant advantage over existing therapies.

What evidence suggests that nicotinamide riboside might be an effective treatment for improving engraftment?

Research suggests that nicotinamide riboside (NR), a type of vitamin B3, might enhance the success of bone marrow transplants. In this trial, participants will receive NR to evaluate its effects on transplant outcomes. Studies have found that NR can increase the number of blood stem cells, potentially speeding up the time for new cells to grow in the body after a transplant. This could reduce the risk of complications and lead to better long-term health. Specifically, NR has increased the number of early-stage cells without exhausting them, significantly improving survival rates. Overall, NR shows promise in supporting healthier cell growth and recovery after a bone marrow transplant.46789

Who Is on the Research Team?

Ronald Sobecks, MD | Cleveland Clinic

Ronald Sobecks, MD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible for a bone marrow transplant with myeloablative conditioning and have an HLA-identical donor. It's not suitable for pregnant or breastfeeding women, those with uncontrolled illnesses or psychiatric conditions that could affect compliance, or anyone allergic to NR compounds like niacin.

Inclusion Criteria

Subjects must provide a written informed consent
I have a matching donor for my bone marrow transplant.
I am eligible and planning to undergo a bone marrow transplant with intensive preparation.
See 1 more

Exclusion Criteria

History of allergy or intolerance to NR precursor compounds, including niacin or nicotinamide
I am not pregnant or breastfeeding.
Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotinamide riboside supplementation to improve engraftment after allogeneic hematopoietic cell transplantation

Up to 21 days
Frequent monitoring visits during treatment

Engraftment Monitoring

Participants are monitored for engraftment, defined as the process during which transplanted stem cells begin to grow in the bone marrow

14-24 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neutrophil and platelet recovery

Up to 100 days

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotinamide Riboside (NR)
Trial Overview The study is testing the addition of Nicotinamide Riboside (NR), a vitamin B supplement, to donor cells in bone marrow transplants. The goal is to see if it can safely increase stem cell numbers and speed up engraftment after the transplant.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Nicotinamide riboside (NR)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Published Research Related to This Trial

A single oral dose of nicotinamide riboside (NR) can significantly increase blood NAD+ levels, with a reported rise of up to 2.7-fold in an individual, indicating its potential efficacy as an NAD+ precursor.
In a clinical trial involving various doses (100, 300, and 1,000 mg), NR was shown to produce dose-dependent increases in blood NAD+ metabolites, and the formation of nicotinic acid adenine dinucleotide (NAAD) from NR was identified as a sensitive biomarker for effective NAD+ repletion.
Nicotinamide riboside is uniquely and orally bioavailable in mice and humans.Trammell, SA., Schmidt, MS., Weidemann, BJ., et al.[2021]
Primitive hematopoietic cells, including myeloid progenitors and hematopoietic stem cells (HSCs), can resist the toxic effects of the antifolate drug trimetrexate (TMTX) by salvaging extracellular nucleotide precursors like thymidine and hypoxanthine.
Using nucleoside transport inhibitors, such as nitrobenzylmercaptopurineriboside phosphate (NBMPR-P), significantly sensitized these progenitor cells and HSCs to TMTX in vivo, leading to a dramatic reduction in their numbers and bone marrow repopulating activity, suggesting a potential strategy to enhance the efficacy of antifolate therapies in cancer treatment.
Sensitization of hematopoietic stem and progenitor cells to trimetrexate using nucleoside transport inhibitors.Allay, JA., Spencer, HT., Wilkinson, SL., et al.[2021]
A gene therapy strategy using the MeiIRG vector can protect bone marrow cells from severe myelosuppression caused by the combination of antifolate drugs and the nucleoside transport inhibitor NBMPR, as shown in both in vitro and in vivo studies.
Mice treated with MeiIRG-transduced bone marrow cells exhibited reduced toxicity, improved blood cell counts, and a survival advantage, suggesting that this approach allows for higher doses of chemotherapy while safeguarding healthy cells.
Retroviral transfer of the hENT2 nucleoside transporter cDNA confers broad-spectrum antifolate resistance in murine bone marrow cells.Patel, DH., Allay, JA., Belt, JA., et al.[2021]

Citations

Nicotinamide riboside attenuates age-associated metabolic ...Here, the authors show nicotinamide riboside treatment shrinks the age-enlarged stem cell pool and shifts aged HSC functionally, metabolically ...
Study of Nicotinamide Riboside Supplementation in ...Research studies have shown that adding nicotinamide riboside to donor cells has the potential to increase blood stem cell numbers and potentially decrease the ...
Nicotinamide Riboside Supplementation to Improve ...Nicotinamide riboside may help decrease the time to engraftment, thereby decrease the risk of complications and improve long-term health status. Eligibility ...
The NAD-Booster Nicotinamide Riboside Potently ...NR dietary supplementation results in a significantly enlarged pool of progenitors, without concurrent HSC exhaustion, improves survival by 80%, ...
Nicotinamide Riboside, a Promising Vitamin B3 Derivative for ...Nicotinamide riboside, a promising vitamin B 3 derivative for healthy aging and longevity: current research and perspectives.
Safety assessment of nicotinamide riboside, a form of ...Results from the study show that NR had a similar toxicity profile to nicotinamide at the highest dose tested. Target organs of toxicity were liver, kidney, ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/26791540/
Safety assessment of nicotinamide riboside, a form ...Results from the study show that NR had a similar toxicity profile to nicotinamide at the highest dose tested. Target organs of toxicity were liver, kidney, ...
Nicotinamide riboside attenuates age-associated ...Here we show that nicotinamide riboside (NR), a form of vitamin B3, restores youthful metabolic capacity by modifying mitochondrial function in multiple ways.
Study of Nicotinamide Riboside Supplementation in ...The purpose of this study is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding nicotinamide ...
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