Comparing biotin-labeled and 51‑chromium–labeled red blood cells after autologous transfusion

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

This test tries to see if biotin-labeled red blood cells can replace radioactive 51Cr-labeled cells to measure red blood cell recovery and survival in healthy adults who donate and receive their own blood.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dana-Farber Cancer Institute (Academic / other)
• Locations: 2 sites (Cincinnati, Ohio and 1 other locations)
• Trial ID: NCT07446647 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, controlled autologous transfusion study compares biotinylated red blood cells (BioRBC) with 51‑chromium (51Cr)-labeled red blood cells to measure recovery and survival after transfusion. Volunteers donate blood that is labeled by one or more methods, stored for 42 days with or without irradiation at Day 0, and then transfused back to the donor. Blood sampling and labeled-cell tracking are performed during follow-up to compare 24‑hour post-transfusion recovery and longer-term survival. About 20 healthy adults will be screened and enrolled based on size, hemoglobin, infectious disease testing and routine laboratory results.

Who should consider this trial

Good fit: Ideal candidates are healthy adults (≥18 years) who meet donor size and hemoglobin criteria, have normal screening laboratory results, negative infectious disease testing, and can donate and receive their own blood.

Not a fit: People with anemia, abnormal lab values, positive infectious disease tests, those who do not meet the donor size or hemoglobin thresholds, or patients who need medical treatment rather than healthy donor procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, biotin labeling could replace radioactive 51Cr methods, providing a non-radioactive, safer way to obtain regulatory red blood cell recovery and survival data.

How similar studies have performed: Both 51Cr and biotin labeling have been used in prior research to track RBC survival, but biotin labeling has not yet been accepted by the FDA for regulatory determination of 24‑hour recovery and long‑term survival.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Cincinnati, Ohio and 1 other locations

• Hoxworth Blood Center, University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• American Red Cross — Norfolk, Virginia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Jose A Cancelas-Perez, MD, PhD — Dana-Farber Cancer Institute
• Study coordinator: Jose A Cancelas-Perez, MD, PhD

Conditions Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused; Healthy volunteers; Red blood cell labeling