Transfusion of Biotinylated Red Blood Cells (b-RBCs)

RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Biotin-Labeled Red Blood Cells (RBCs)

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Biotin-Labeled Red Blood Cell (RBC) Infusion; 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.

Drug: Biotin-Labeled Red Blood Cells (RBCs); 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Had bRBC Detectable at 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	70 days post-intervention
Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another	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	Up to 112 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: John D Roback, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): November 13, 2018
• Study Completion (Actual): November 13, 2018

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Red Blood Cell (RBC) transfusion; Biotin labeled red blood cells
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Biotin
• Other Study ID Numbers: IRB00085954; R01HL095479-06 (U.S. NIH Grant/Contract); P01HL086773-06A1 (U.S. NIH Grant/Contract)