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
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Biotin-Labeled Red Blood Cells (RBCs)||Phase 1|
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 (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|
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.
- 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
- 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
- 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.
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
|Contact: John D Roback, MD, PhDfirstname.lastname@example.org|
|Contact: Shannon Bonds, RN||(404) email@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: John D Roback, MD, PhD 404-712-1774 firstname.lastname@example.org|
|Principal Investigator:||John D Roback, MD, PhD||Emory University|