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

NCT07446647 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Biotinylated Red Blood Cells (BioRBC)

Intravenous infusion

BIOLOGICAL

Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)

Intravenous infusion

BIOLOGICAL

51 Chromium Labeled Red Blood Cells (51Cr RBC)

Intravenous infusion

BIOLOGICAL

Technetium 99m Labeled Red Blood Cells (99mTc RBC)

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Jose A Cancelas-Perez, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446647 on ClinicalTrials.gov