Transfusion of Biotinylated Red Blood Cells

Anemia Clinical Trial

— b-RBCs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757898
• Other study ID #: IRB00085954
• Secondary ID: R01HL095479-06P0
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2017
• Est. completion date: November 13, 2018

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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