NCT07446647 · Jose Cancelas
Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
What this 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 how the drug moves through the body studies of red blood cell products.
View original scientific description
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.
Interventions
BIOLOGICAL
Biotinylated Red Blood Cells (BioRBC)
Intravenous infusion
BIOLOGICAL
Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)
Intravenous infusion
BIOLOGICAL
51 Chromium Labeled Red Blood Cells (51Cr RBC)
Intravenous infusion
BIOLOGICAL
Technetium 99m Labeled Red Blood Cells (99mTc RBC)
Intravenous infusion
Primary outcome measures
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)
Percentage of infused autologous red blood cells (RBC) remaining in circulation 24 hours after transfusion
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).
Survival of autologous irradiated RBC expressed as days of RBC present in blood until they disappear from circulation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cincinnati, Ohio
- Norfolk, Virginia
Collaborators
Department of Health and Human Services
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations