Clinical trial for Sickle Cell Disease
Official title Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
ClinicalTrials.gov ID: NCT06313398
What this study is testing
What is Biotin-labeled red blood cells?
An investigational cellular product being studied for sickle cell disease
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how long red blood cells survive in people with sickle cell disease or other inherited blood disorders, and how this compares to people whose disease was cured with a bone marrow transplant.
- Who it's for
- Adults 18 years or older who have sickle cell disease or another inherited blood disorder, including those who have had a bone marrow transplant.
- What's involved
- Participants will have a large blood draw (about 7 tablespoons) that is mixed with biotin in a lab. The biotin‑labeled red cells are then returned to the participant’s bloodstream. After that, participants will come back for smaller blood samples (about 2 teaspoons) to check how many labeled cells remain. Visits may be every 2 or 4 weeks or at other intervals.
- Time commitment
- The study lasts up to 20 weeks, with regular visits for blood tests and monitoring of labeled cells.
- Phase 1: an early, usually small safety study
- Time commitment: about 20 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or greater with confirmed diagnosis of SCD (all genotypes), thalassemia (beta and/or alpha), or other inherited...
- Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history.
- Ability to have blood samples drawn.
You likely can't join if
- Consumption of biotin supplements or raw eggs within the last 30 days.
- Blood loss within the previous 8 weeks (\>540 mL).
- Red cell transfusion for their underlying SCD and/or thalassemia within the last 3 months. a.
- Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs.
- Pregnancy, lactation or absence of adequate contraception for fertile female people.
- Pediatric people will not participate in this study.
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 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.
- Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history.
- Ability to have blood samples drawn.
- For female participants of child-bearing potential, agree to use birth control during study participation.
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Consumption of biotin supplements or raw eggs within the last 30 days.
- Blood loss within the previous 8 weeks (\>540 mL).
- 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.
- Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs.
- Pregnancy, lactation or absence of adequate contraception for fertile female people.
- Pediatric people will not participate in this study.
- Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction.
- Current diagnosis of malignancy (liquid and/or solid).
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 20 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.