Allogeneic Hematopoietic Cell Transplantation

Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days

Nicotinamide riboside (NR)

Cleveland Clinic, Case Comprehensive Cancer Center

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Tolerability of NR in allogeneic HCT recipients, defined as 8 or more of 15 participants (i.e. at least 50% of enrolled subjects) able to receive >75% of their scheduled doses (overall rate 53%, 95% confidence intervals 33%-86%). This will include both patients who discontinue NR due to study drug related toxicity and patients who are not able to stay on NR due to transplant related toxicity that limits ability to take the drug

Safety of NR in allogeneic HCT recipients as measured by percent of participants experiencing a CTCAE 5.0 grade 3 or higher that is related to the study drug

Median and range of days to neutrophil recovery after HCT. Recovery defined as first day of three consecutive days with absolute neutrophil count 500 cells/mm3 (0.5 x 109/L) or greater

Median and range of days to Platelet recovery after HCT. Recovery defined as first day of three consecutive days with platelet count 20,000/mm3 (20 x 109/L) or greater and unsupported by platelet transfusions.

Case Comprehensive Cancer Center

Participants randomized to placebo will take 2 capsules by mouth twice a day for 6 months. The placebo capsules are matched to the NR capsules.

Participants randomized to Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) will take 250 mg capsules. Participants will take 2 capsules by mouth twice a day (1000 mg) for 6 months

Diabetic Neuropathy Peripheral

Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) will be the experimental treatment, at a dose of 1000 mg/day taken as two 250 mg capsules twice daily for 6 months.

Niagen

Placebo capsules matched to the experimental drug and taken orally as 2 capsules twice daily for 6 months.

Placebo

University of Maryland

Nicotinamide Riboside for Diabetic Neuropathy

Nicotinamide Riboside in Diabetic Polyneuropathy

Change in the proximal thigh Intra-Epidermal Nerve Fiber Density as assessed by skin biopsy. Smaller values indicate worse neuropathy. Normative ranges depend on age and gender.

Change in the distal leg Intra-epidermal Nerve Fiber Density as assessed by biopsy. Smaller values indicate worse neuropathy. Normative ranges depend on age and gender.

Modified Toronto Clinical Neuropathy Scale to assess clinical symptoms and signs of diabetic neuropathy

The Neuropathy Total Symptom Score ranges from 0 to 21.96 points with higher scores indicating a worse symptom score

To evaluate the neuropathic pain and non-neuropathic pain. The Pain Quality Assessment Scale was developed from the neuropathy Pain Scale and is a 20 item scale that assesses both neuropathic pain and non-neuropathic pain. Higher score indicate worse pain.

Survey of Autonomic Symptoms to assess symptoms of peripheral autonomic function. The scale varies depending on gender. Higher scores indicate higher levels of autonomic symptoms.

This measures quality of life and is an 11 item scale with each item scored from 0 to create an aggregate scale. High scores are worse.

Nerve Conduction Studies to assess changes in nerve conduction. The amplitudes of the sural sensory, fibular motor, tibial motor and their respective distal latencies, and conduction velocities are obtained. Data will be used from individual measurements and using a mega score of combined variables. Lower scores may indicate neuropathy.

The expiration:inspiration ratio will be measured. Normative data varies depending on age, gender and other factors. Lower scores may indicate cardiac autonomic neuropathy.

James W. Russell, MD, MS

Professor

University of Maryland, Baltimore

US Department of Veterans Affairs

Duodenal biopsy samples and saliva will be collected from participants and then processed in laboratory to generate intestinal stem cell-derived enteroids.

Gastrointestinal Infection

Two duodenal biopsy samples will be collected from each participant

Duodenal biopsy

Saliva (1-2 mL) will be collected from each participant for secretor status testing

nicotinamide/hemorrhage

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Nicotinamide Riboside for Diabetic Neuropathy

Identification of Host Factors of Norovirus Infections in Mini-Gut Model

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