NCT07446647 Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
| NCT ID | NCT07446647 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jose Cancelas |
| Condition | Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-04-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jose A Cancelas-Perez, MD, PhD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT07446647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07446647 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07446647 currently recruiting?
Yes, NCT07446647 is actively recruiting participants. Contact the research team at jose_cancelas-perez@dfci.harvard.edu for enrollment information.
Where is the NCT07446647 trial being conducted?
This trial is being conducted at Cincinnati, United States, Norfolk, United States.
Who is sponsoring the NCT07446647 clinical trial?
NCT07446647 is sponsored by Jose Cancelas. The principal investigator is Jose A Cancelas-Perez, MD, PhD at Dana-Farber Cancer Institute. The trial plans to enroll 20 participants.