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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jose_cancelas-perez@dfci.harvard.edu
• Phone: 617-632-3446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.