Recruiting
Phase 1

BioRBC vs. 51Cr

Sponsor:

Jose Cancelas

Code:

NCT07446647

Conditions

Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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)

Study Details

Brief 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

Study ID

NCT07446647

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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).

Interventions

Biotinylated Red Blood Cells (BioRBC)

Intravenous infusion

Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)

Intravenous infusion

51 Chromium Labeled Red Blood Cells (51Cr RBC)

Intravenous infusion

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

Intravenous infusion

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) ]
  • Lifespan of of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [ Time Frame: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion). ]

Central Contacts and Locations

Central contacts

Jose A Cancelas-Perez, MD, PhD

617-632-3446jose_cancelas-perez@dfci.harvard.edu

Locations

Hoxworth Blood Center, University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Neeta Rugg, MS

513-558-1503neeta.rugg@uc.edu

Principal Investigator:

Sachie Ikegami, MD, PhD

More Information

Sponsor

Jose Cancelas

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Healthy volunteers
  • Red blood cell labeling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jose Cancelas on 2026-04-16.