Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT04476277 |
Recruitment Status :
Recruiting
First Posted : July 20, 2020
Last Update Posted : May 18, 2022
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Background:
Sickle cell disease (SCD) is an inherited blood disorder. It results from a single genetic change (mutation) in red blood cells (RBCs). RBCs are the cells that carry oxygen to the body. In people with SCD, some RBCs are abnormal and die early. This leaves a shortage of healthy RBCs. Researchers want to learn more about how long RBCs live in the human body.
Objective:
To study how long RBCs live in people with and without SCD.
Eligibility:
People age 18 and older who either have SCD, had SCD but were cured with a bone marrow transplant, have the sickle cell trait (SCT), or are a healthy volunteer without SCD or SCT
Design:
Participants will be screened with a medical history and physical exam. They will give a blood sample.
Participants will have a small amount of blood drawn from a vein. In the laboratory, the blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs without changing their function, shape, or overall lifetime. This process is known as biotin labeling of RBCs. The biotin labeled RBCs will be returned to the participant via vein injection.
Participants will give frequent blood samples. Their RBCs will be studied to see how many biotin labeled RBCs remain over time. This shows how long the RBCs live. Participants will give blood samples until no biotin labeled RBCs can be detected.
During the study visits, participants will report any major changes to their health.
Participation lasts for up to 6 months.
Condition or disease | Intervention/treatment | Phase |
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Sickle Cell Disease Sickle Cell Anemia | Drug: Biotin label | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 21 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease |
Actual Study Start Date : | April 19, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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Experimental: 1
Autologous cells will be collected and biotin-labeled ex vivo and reinfused to measure red cell survival
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Drug: Biotin label
Autologous cells will be collected and biotin-labeled ex vivo and reinfused to measure red cell survival |
- To determine and compare red blood cell survival in patients with SCD (HbSS genotype), patients with SCD who have undergone BMT, subjects with SCT, and healthy donors [ Time Frame: 6 months ]Percentage of red blood cells at specific time points as measured by flow cytometry.
- To create a mathematical model incorporating RBC survival and reticulocyte count to determine the necessary amount of normal hemoglobin, and therefore VCN, required for gene therapy protocols [ Time Frame: 18 months ]Design completion of mathematical model

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
- Age 18 or greater with a confirmed diagnosis of homozygous SCD (HbSS, HbSC, HbSB0), sickle cell trait (HbAS), or healthy volunteer (HbA)
- Normal renal function: creatinine <1.5 mg/dL
- Negative direct antiglobulin test (DAT)
- Ability to give informed consent to participate in the protocol
EXCLUSION CRITERIA:
- Any uncontrolled chronic illness other than sickle cell disease
- Active viral, bacterial, fungal, or parasitic infection
- Consumption of biotin supplements or raw eggs within 30 days
- Blood loss within the previous 8 weeks >540mL
- Pregnancy
- Pre-existing, naturally occurring antibodies against biotin

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476277
Contact: Christina C Luckett | (301) 827-7901 | christina.luckett@nih.gov | |
Contact: John F Tisdale, M.D. | (301) 402-6497 | johntis@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | John F Tisdale, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT04476277 |
Other Study ID Numbers: |
200080 20-H-0080 |
First Posted: | July 20, 2020 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | March 22, 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Red Cell Survival Biotin Sickle Cell Anemia Sickle Cell Disease Sickle Cell Trait |
Anemia, Sickle Cell Anemia Hematologic Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies |
Genetic Diseases, Inborn Biotin Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |