Measures how long red blood cells last in sickle cell disease
Tracks how long a person's own labeled red blood cells survive in sickle cell disease.
Plain-language title generated from the registry record
Registry title: Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
Key facts
- Where
- Bethesda, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06313398, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Heart, Lung, and Blood Institute (NHLBI)
- Trial code
- NCT06313398
- Record updated
- 28 September 2026
- Original description
Background:Read full original descriptionShow less
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
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....
Exclusion: Blood loss within the previous 8 weeks (>540 mL); Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction; Current diagnosis of malignancy (liquid and/or solid); 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; Red cell transfusion for their underlying SCD and/or thalassemia within the last 3 months; 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.
INCLUSION CRITERIA:; In order to be eligible to participate in this study, an individual must meet all of the following criteria:; Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged 18 years or greater with confirmed diagnosis of SCD (all genotypes), thalassemia (beta and/or alpha), or other inherited hemoglobinopathy not otherwise specified; Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history; Ability to have blood samples drawn; For female participants of child-bearing potential, agree to use birth control during study participation. Female subjects of child-bearing potential must agree to use a medically acceptable method of birth control such as an oral contraceptive, intrauterine device, barrier and spermicide, or contraceptive implant/injection from start of screening through 4 months after infusion; Agreement to adhere to Lifestyle Considerations throughout study duration.