How long do red blood cells live? new study uses biotin to find out
NCT ID NCT06313398
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study aims to measure how long red blood cells survive in people with sickle cell disease, thalassemia, and other inherited blood disorders. Researchers will take a blood sample, label the red cells with biotin (a vitamin), and infuse them back into the participant. Over up to 20 weeks, they will track how long the labeled cells last. The study includes adults with these conditions and those who have been cured by a bone marrow transplant, to compare survival times.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biotin-labeled red blood cells
- What this could lead to
- If successful, this could help doctors better understand how treatments like bone marrow transplant affect red blood cell survival in blood disorders.
- What could go wrong
- This is an early-phase observational study, not a treatment trial. It may not lead to any direct benefit for participants, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. 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. 4. Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history. 5. Ability to have blood samples drawn. 6. 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. 7. Agreement to adhere to Lifestyle Considerations throughout study duration EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Consumption of biotin supplements or raw eggs within the last 30 days. 2. Blood loss within the previous 8 weeks (\>540 mL). 3. Red cell transfusion for their underlying SCD and/or thalassemia within the last 3 months. a. Participants may be eligible after three months following their last transfusion. 4. Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs. 5. Pregnancy, lactation or absence of adequate contraception for fertile female subjects. 6. Pediatric subjects will not participate in this study. 7. Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction. 8. Current diagnosis of malignancy (liquid and/or solid).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sickle cell clues to diabetes risk hidden in DNA
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
- Tiny biochip could reveal sickle cell severity
- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?