Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transfusion of Biotinylated Red Blood Cells (b-RBCs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02757898
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
John D Roback, 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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Biotin-Labeled Red Blood Cells (RBCs) Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival
Actual Study Start Date : January 11, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Biotin

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)

500mL 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 2-6C 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.





Primary Outcome Measures :
  1. Length of time biotin-labeled RBCs can be detected following re-infusion [ Time Frame: Up to 112 days ]
    The length of time biotin-labeled RBCs can be detected following re-infusion will be determined by taking blood samples from each participant for 70 days

  2. Length of time differentially labeled biotin-labeled RBCs can be distinguished from one another [ Time Frame: 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 :
  1. Number of participants experiencing adverse events [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757898


Contacts
Layout table for location contacts
Contact: John D Roback, MD, PhD 404-712-1774 jroback@emory.edu
Contact: Shannon Bonds, RN (404) 712-0767 sbonds@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: John D Roback, MD, PhD    404-712-1774    jroback@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: John D Roback, MD, PhD Emory University

Layout table for additonal information
Responsible Party: John D Roback, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02757898     History of Changes
Other Study ID Numbers: IRB00085954
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

Keywords provided by John D Roback, Emory University:
Red Blood Cell (RBC) transfusion
Biotin labeled red blood cells

Additional relevant MeSH terms:
Layout table for MeSH terms
Biotin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs