Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies

This study is looking at how long red blood cells (RBCs) survive in people with sickle cell disease (SCD) and other inherited blood disorders like thalassemia. Researchers want to compare RBC survival in people who have not had a transplant to those who have had a bone marrow transplant. You would receive an infusion of your own red blood cells that have been labeled with biotin. The study aims to measure how many days these labeled RBCs can be detected in your body. This information will help doctors better understand these conditions and the effects of treatments. The study plans to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants aged 18 to 100 years old.
What's involved
If you haven't had a transplant, you will have lab draws every two weeks until the biotin-labeled cells are no longer detected. If you have had a transplant, you will have lab draws every four weeks until week 12, then every two weeks until the biotin-labeled cells are no longer detected.
Compensation
Not stated in the trial record.
Follow-up
For participants without a transplant, follow-up involves lab draws every two weeks until biotin-labeled red blood cells are no longer detected. For participants post-transplant, follow-up involves lab draws every four weeks until week 12, then every two weeks until biotin-labeled red blood cells are no longer detected.

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NCT06313398

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

Recruiting
EARLY_PHASE1Ages 18+Interventional
National Heart, Lung, and Blood Institute (NHLBI)
~100 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:Biotin-labeled red blood cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies.
Measured over Patients w/o transplant: lab draw every 2 weeks until biotin-labeled cells are no longer detected. Patients Post-transplant: lab draw every four weeks, until week 12. Lab draw every 2 weeks until biotin-labeled cells are no longer detected.
Sickle Cell Disease
Thalassemia
Hemoglobinopathy
1 sites across 1 states
Maryland1
  • John F Tisdale, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

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  • To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies.Patients w/o transplant: lab draw every 2 weeks until biotin-labeled cells are no longer detected. Patients Post-transplant: lab draw every four weeks, until week 12. Lab draw every 2 weeks until biotin-labeled cells are no longer detected.

    Enumeration of biotin-labeled RBCS (BioRBCs) will be performed by flow cytometry. F-cell and/or S-cell measurement will be done by flow cytometry. BioRBCs will be isolated from post-infusion blood samples using flow cytometry separation. The collected BioRBCs and the whole blood fraction will be analyzed by high performance liquid chromatography (HPLC) for hemoglobin content.