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RecruitingPhase 1NCT07446647

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

Sponsor

Jose Cancelas

Enrollment

20 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Signed and dated informed consent form.
  • Age ≥18 years, of either gender.
  • Normal health status (as determined by Investigators' review of medical history and physical exam).
  • Qualifies for a collection; Males: height >5'1" and weight >130 lbs; Females: height >5' 5" and weight > 150 lbs.
  • Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST, total bilirubin, BUN, creatinine, and ferritin). Values outside of normal reference range if considered not to be clinically significant by the site PI may be allowed as per the site PI.
  • Hemoglobin levels >13.3 g/dL and hematocrit >40% for both male and female subjects.
  • Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, and WNV virus at the time of donation.
  • Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
  • Meet or exceed AABB guidelines for blood donation, with the exception of travel deferrals as defined by site-specific SOPs.

Exclusion Criteria9

  • Known RBC disorder that could affect RBC survival.
  • Treatment with any medication known to affect RBC viability.
  • Pregnant or nursing female.
  • Male subjects or female subjects of childbearing potential not using medically acceptable contraceptive methods.
  • Participation in another clinical study currently or within the past 28 days.
  • Subjects not eligible to provide a double RBC donation per AABB guidelines for blood donation.
  • Subjects who have received blood transfusion within the previous year.
  • Known pre-existing antibody specific to BioRBC.
  • Subjects who have received a previous infusion of BioRBC at any time.

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Interventions

BIOLOGICALBiotinylated Red Blood Cells (BioRBC)

Intravenous infusion

BIOLOGICALIrradiated Biotinylated Red Blood Cells (Irradiated BioRBC)

Intravenous infusion

BIOLOGICAL51 Chromium Labeled Red Blood Cells (51Cr RBC)

Intravenous infusion

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

Intravenous infusion

Locations(2)

Hoxworth Blood Center, University of Cincinnati

Cincinnati, Ohio, United States

American Red Cross

Norfolk, Virginia, United States

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NCT07446647