NCT04332341

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 riboside to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment. Also, nicotinamide riboside, TRU NIAGEN (the study drug) is a type of vitamin B supplement that the general public can get without a prescription and is well tolerated.

Detailed description

This is a single-center, pilot feasibility study of NR supplementation in allogeneic (donor) HCT in which the study team is seeking to obtain preliminary data on any beneficial effect of increasing NAD+ levels in-vivo to facilitate engraftment. Engraftment is defined as the process during which transplanted stem cells begin to grow in the bone marrow and produce new white blood cells, red blood cells, and platelets. It takes about 14 to 24 days for donor cells to engraft after infusion, and the time between which blood counts fall to the time when they recover is a very critical period. Transfusions are frequently required to prevent bleeding and antibiotics are needed to prevent infections during this critical time period. Shortening the time of engraftment decreases these risks and can improve long-term health status. The primary objectives of this study is to evaluate safety and tolerability of NR supplementation The secondary objective of this study is to evaluate neutrophil and platelet recovery after HCT

Conditions

• Allogeneic Hematopoietic Cell Transplantation

Interventions

Type	Name	Description
DRUG	Nicotinamide riboside (NR)	Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days

Timeline

• Start date: 2020-05-19
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2020-04-02
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study