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Red Blood Cell Survival Study for Sickle Cell Disease

Phase 1
Recruiting
Led By Marianne Yee, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
receiving CTT for ≥3 months prior to enrollment
HbSS or HbSβ0 thalassemia SCD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, weeks 1-12
Awards & highlights

Study Summary

This trial is measuring the survival of transfused red blood cells in people with sickle cell disease who are receiving chronic transfusion therapy.

Who is the study for?
This trial is for individuals with Sickle Cell Disease (SCD), specifically HbSS or HbSβ0 thalassemia, who have been receiving regular blood transfusions for at least 3 months. It's not suitable for those on hydroxyurea therapy, taking high-dose biotin or raw egg supplements, expecting to stop transfusions soon, having had certain blood exchange therapies or reactions recently, or are currently pregnant.Check my eligibility
What is being tested?
The study tests how long transfused red blood cells last in patients with SCD undergoing chronic transfusion therapy. Participants will receive biotin-labeled RBCs during a normal transfusion and then be monitored regularly up to six months. An optional part of the study uses INTERCEPT-treated RBCs to compare survival rates.See study design
What are the potential side effects?
While the main focus is on observing RBC survival rather than side effects, potential risks may include allergic reactions from labeled RBCs and complications related to frequent blood draws such as bruising or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on hormone therapy for at least 3 months.
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I have sickle cell disease, either HbSS or HbSβ0 thalassemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 1-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, weeks 1-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Number of Biotin Labeled RBCs
Half-life of Biotinylated RBCs
Mean Potential Lifespan (MPL) of Biotinylated RBCs

Trial Design

1Treatment groups
Experimental Treatment
Group I: Biotin labeled Red Blood CellsExperimental Treatment2 Interventions
Participants receiving a transfusion with biotin labeled RBCs. Samples will be taken for 12 weeks after the biotinylated transfusion. During this time participants will continue to receive regular monthly transfusions (non-biotinylated) as part of CTT.

Find a Location

Who is running the clinical trial?

Cerus CorporationIndustry Sponsor
18 Previous Clinical Trials
4,828 Total Patients Enrolled
Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,437 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,717 Total Patients Enrolled

Media Library

Biotin Labeled Red Blood Cells (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04426591 — Phase 1
Sickle Cell Disease Research Study Groups: Biotin labeled Red Blood Cells
Sickle Cell Disease Clinical Trial 2023: Biotin Labeled Red Blood Cells Highlights & Side Effects. Trial Name: NCT04426591 — Phase 1
Biotin Labeled Red Blood Cells (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04426591 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any previous research conducted using Biotin Labeled Red Blood Cells?

"Currently, 5 trials are active researching Biotin Labeled Red Blood Cells - one of which is at the critical Phase 3 stage. While the main research hub for this treatment is located in Bethesda, Maryland, there are 7 additional sites running their own investigations."

Answered by AI

How many subjects are currently taking part in this experiment?

"Indeed, the data hosted on clinicaltrials.gov attests that this medical experiment is actively seeking volunteers. It was initially posted in October 2021 and subsequently updated later that month. 40 participants must be sourced from 3 different sites to fulfill its requirements."

Answered by AI

Is this medical research still open to recruitment?

"Affirmative. Clinicaltrials.gov provides information that this clinical trial, initially posted on October 29th 2021, is now searching for participants. A total of 40 individuals need to be enrolled from 3 distinct medical centres."

Answered by AI

Has the utilization of Biotin Labeled Red Blood Cells been ratified by the FDA?

"Since this is a Phase 1 trial and there is only minimal evidence of safety and efficacy, the risk associated with Biotin Labeled Red Blood Cells was assessed as low (level 1) by our team at Power."

Answered by AI
~12 spots leftby May 2025