Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion

Conditions

• Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Biotinylated Red Blood Cells (BioRBC) — BIOLOGICAL
  Intravenous infusion
• Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC) — BIOLOGICAL
  Intravenous infusion
• 51 Chromium Labeled Red Blood Cells (51Cr RBC) — BIOLOGICAL
  Intravenous infusion
• Technetium 99m Labeled Red Blood Cells (99mTc RBC) — BIOLOGICAL
  Intravenous infusion

Study Details

This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Unirradiated Red Blood Cells
  Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized. Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).
• Experimental: Gamma Irradiated Red Blood Cells
  Day 42: Samples from each unit are labeled with biotin at one density and 51Cr. Assignments of biotin density and 51-Cr are randomized. Participants are infused with four types of manipulated RBCs (Stored Test (Irradiated), Stored Control (Non-Irradiated), Stored Control or Test RBCs labeled with 51Cr, Fresh RBCs with 99mTc) and one type of unmanipulated RBCs (Non-Irradiated or Irradiated, non-labeled RBCs).

Primary Outcome Measure

24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [ Time Frame: Day 1 after completion of autologous RBC infusion (Day 43 of the study) ]

Central Contacts

• Jose A Cancelas-Perez, MD, PhD
  617-632-3446
  [email protected]

Locations (2)

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