Transfusion of Biotinylated Red Blood Cells (b-RBCs)

Emory University

Status and phase: Completed; Phase 1

Conditions: Anemia

Treatments: Drug: Biotin-Labeled Red Blood Cells (RBCs)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02757898

IRB00085954

P01HL086773-06A1 (U.S. NIH Grant/Contract)

R01HL095479-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in good health

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Biotin-Labeled Red Blood Cell (RBC) Infusion

Experimental group

Description:

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.

Treatment:

Drug: Biotin-Labeled Red Blood Cells (RBCs)