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
6 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
Researchers are studying how long red blood cells (RBCs) survive in people with sickle cell disease (SCD) and other inherited blood disorders, such as thalassemia. The study aims to compare RBC lifespan in those undergoing disease modifying treatments or those who have been cured with bone marrow transplants. This research will help understand how treatments affect RBC survival and the degree of correction needed to reverse symptoms in these conditions. Participants will have their own RBCs labeled with a vitamin called biotin in the lab, which sticks to the RBCs' surface. These biotin-labeled RBCs are then infused back into the participant's bloodstream. The study will track the lifespan of these cells by drawing smaller blood samples regularly, every 2 to 4 weeks, for up to 20 weeks or until labeled cells are no longer detected. The study includes patients before and after disease modifying therapy or hematopoietic stem cell transplantation (HSCT). During the study, participants will undergo physical exams, blood and urine tests, and blood draws to measure the percentage of biotin-labeled RBCs. Researchers will monitor RBC survival over time and relate it to blood markers like reticulocyte count and hemoglobin levels. Participants will be followed for up to 20 weeks, with more frequent blood tests early on. The main outcome is the average number of days biotin-labeled RBCs remain detectable, helping to understand treatment effects on blood cell lifespan.
CONDITIONS
Brief 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 comply with all study procedures and availability for the study duration
- Male or female, aged 18 years or older with confirmed diagnosis of sickle cell disease, thalassemia, or other inherited hemoglobinopathy
- At steady state for their disease or post-bone marrow transplant status
- Ability to have blood samples drawn
- For females of child-bearing potential, agreement to use birth control during participation
- Agreement to follow lifestyle considerations during the study
You will not qualify if you...
- Use of biotin supplements or raw eggs within the last 30 days
- Blood loss greater than 540 mL within the previous 8 weeks
- Red cell transfusion within the last 3 months
- Currently on hemodialysis
- Pregnant, breastfeeding, or lack of adequate contraception for fertile females
- Under 18 years old
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies until biotin-labeled red blood cells are no longer detected, up to 12 weeks post-transplant
Participants receive biotin-labeled red blood cells infused back to themselves to measure red blood cell survival.
Lab draws every 2 weeks for participants without transplant until labeled cells are undetectable; lab draws every 4 weeks until week 12 for participants post-transplant
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
J
John F Tisdale, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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