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New treatment option for Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused
Official title Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
ClinicalTrials.gov ID: NCT07446647
What this study is testing
What is Biotinylated Red Blood Cells (BioRBC)?
Biotinylated Red Blood Cells (BioRBC) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy volunteer red blood cell labeling study; not disease focused.
Also referred to as BioRBC, Biotin labeled red blood cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Known RBC disorder that could affect RBC survival.
- Treatment with any medication known to affect RBC viability.
- Pregnant or nursing female.
- Male people or female people of childbearing potential not using medically acceptable contraceptive methods.
- Participation in another clinical study currently or within the past 28 days.
- people not eligible to provide a double RBC donation per AABB guidelines for blood donation.
See the full eligibility 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...
- Hemoglobin levels \>13.3 g/dL and hematocrit \>40% for both male and female people.
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, and WNV virus at the time of donation.
- Female people of childbearing potential and male people must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of...
- Meet or exceed AABB guidelines for blood donation, with the exception of travel deferrals as defined by site-specific SOPs.
- Known RBC disorder that could affect RBC survival.
- Treatment with any medication known to affect RBC viability.
- Pregnant or nursing female.
- Male people or female people of childbearing potential not using medically acceptable contraceptive methods.
- Participation in another clinical study currently or within the past 28 days.
- people not eligible to provide a double RBC donation per AABB guidelines for blood donation.
- people who have received blood transfusion within the previous year.
- Known pre-existing antibody specific to BioRBC.
- people who have received a previous infusion of BioRBC at any time.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States; Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.