Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling

Recruiting now · Early Phase 1

Conditions studied: Sickle Cell Disease, Thalassemia, Hemoglobinopathy

In brief

Background: Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant. Objective: To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant. Eligibility: People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream. Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected....

Key facts

Study ID

NCT06313398

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

100

Starts

2024-05-17

Expected to finish

2029-06-15

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Consumption of biotin supplements or raw eggs within the last 30 days.
• Blood loss within the previous 8 weeks (>540 mL).
• Red cell transfusion for their underlying SCD and/or thalassemia within the last 3 months.
• a. Participants may be eligible after three months following their last transfusion.
• Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs.
• Pregnancy, lactation or absence of adequate contraception for fertile female subjects.
• Pediatric subjects will not participate in this study.
• Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction.
• Current diagnosis of malignancy (liquid and/or solid).

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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