Actively Recruiting
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-02-24
100
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
N
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
C
Children's National Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 18 years or older with confirmed sickle cell disease, thalassemia, or other inherited hemoglobinopathy
- Stable condition with steady state of disease or post-bone marrow transplant status
- Ability to have blood samples drawn
- Females of child-bearing potential agree to use medically accepted birth control during the study and for 4 months after infusion
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Use of biotin supplements or raw eggs in the last 30 days
- Blood loss greater than 540 mL within the last 8 weeks
- Red cell transfusion within the last 3 months (may be eligible after 3 months)
- Currently on hemodialysis
- Pregnancy, breastfeeding, or inadequate contraception for fertile females
- Age below 18 years (pediatric subjects not included)
- Known allergy to biotin
- Current diagnosis of any cancer (liquid or solid)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Christina C Luckett
CONTACT
J
John F Tisdale, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here