NCT06788080

Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion

Optimization of Biotinylation Protocol for Next Generation Studies of Red Blood Cell Survival and Function After Transfusion

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vitalant Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)

Detailed description

The objective of this open label, pilot, single center, trial of biotinylated red blood cells (BioRBCs) is to determine the impact of RBC biotinylation timing (48h vs 6h prior to transfusion) on autologous BioRBCs posttransfusion recovery in 12 healthy subjects. The rationale is to determine the feasibility of manufacturing BioRBC at a central site that is remote from the site of the clinical study, where transfusion occurs. Manufacturing and transportation will result in a delayed (up to 48 hrs.) transfusion of the BioRBCs. In this trial each subject will donate one unit of autologous whole blood which will be manufactured into leukoreduced packed RBCs (pRBCs) in additive solution-1 (AS-1) and stored for 42 days. Biotin labelling of the pRBCs will occur at 2 different time points, after 35-40 days of storage or after 37-42 days of storage with 2 different doses of biotin (3 µg/mL vs 15 µg/mL). Subjects will be stratified at the time of enrollment (first 6 subjects enrolled vs last 6 subjects enrolled) to a labelling sequence related to both the dose of biotin label and the time of labelling. The stratification sequence is defined by subjects with an earlier enrollment (first 6 subjects enrolled) who will have low dose biotin label (3µg/mL) after storage of autologous pRBCs at the earlier time point (35-40 days), and the high dose biotin label (15µg/mL) after storage of autologous pRBCs at the later time point (37-42 days). The alternative labelling procedure, for subjects enrolled later on study (last 6 subjects enrolled), will utilize the high dose biotin label (15 µg/mL) after storage of autologous pRBCs at the earlier time point (35-40 days) and the low dose biotin label (3µg/mL) after storage of autologous pRBCs at the later time point (37-42 days). This stratification is designed to result in the second biotin labelling to occur on the day of transfusion (which is also approximately 2 days after the first biotinylation process). Thus, each subject will receive a total of two sequential 10 mL doses of BioRBCs during one infusion visit.

Conditions

• Measuring Red Blood Cell Survival After Transfusion

Interventions

Type	Name	Description
DRUG	BioRBC	Autologous biotin-labeled RBCs will be transfused to study participants

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2025-01-22
• Last updated: 2025-01-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study