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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

Jose Cancelas · with Department of Health and Human Services · NCT07446647

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
20
US sites recruiting
1
Study start
April 1, 2026
Record last updated
April 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Biotinylated Red Blood Cells (BioRBC); Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC); 51 Chromium Labeled Red Blood Cells (51Cr RBC); Technetium 99m Labeled Red Blood Cells (99mTc RBC)

Conditions: Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Hoxworth Blood Center, University of Cincinnati

    Cincinnati, OH 45267

    Site contact: Neeta Rugg, MS · 513-558-1503 · neeta.rugg@uc.edu

Study contacts (from the official record)

  • Jose A Cancelas-Perez, MD, PhD · 617-632-3446 · jose_cancelas-perez@dfci.harvard.edu
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Comparative Analysis of Biotinylated, Irradiated and 51-Chromium… (NCT07446647) | Bored Studies