Transfusion of Biotinylated Red Blood Cells

Phase 1

Completed

• Conditions: Anemia
• Interventions: Drug: Biotin-Labeled Red Blood Cells (RBCs)

• Registration Number: NCT02757898
• Lead Sponsor: Emory University

Brief Summary

The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.

Detailed Description

The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused.

In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.

This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs.

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Start: 2017-01-11
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Results First Submitted: 2023-03-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Results First Posted: 2023-05-09
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• in good health

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Exclusion Criteria

• anemia (defined as hemoglobin < 8 g/dL)
• chronic disease, including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease
• ongoing consumption of biotin or raw egg supplements
• history of a bleeding disorder
• evidence of anemia at initial screening
• women who are pregnant or plan to become pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biotin-Labeled Red Blood Cell (RBC) Infusion	Biotin-Labeled Red Blood Cells (RBCs)	Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had bRBC Detectable at 70 Days Post-intervention	70 days post-intervention	The length of time biotin-labeled RBCs can be detected following re-infusion. The number of participants was determined at day 70 by taking blood samples from each of them
Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another	Up to 112 days	The length of time that the three different concentrations of biotin labeling on the RBCs can be distinguished from one another will be determined by taking blood samples from each participant for 70 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	Up to 12 months	The total number of participants who experience adverse events, including development of anti-biotin-RBC antibodies will be determined. In previous studies, antibodies for biotin-labeled RBCs have been seen in a small number of people for up to 12 months.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States