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Official title A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
ClinicalTrials.gov ID: NCT07015437
What this study is testing
- What it's testing
- The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.
- Phase 2: a mid-size study of how well it works
- 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
- Age ≥18 years
- Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator...
- Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the...
- people of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
You likely can't join if
- History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and...
- Positive DAT or IAT at study entry
- Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- Treatment with any medication known to affect RBC viability
- Pregnant or nursing females
See the full eligibility criteria
- Age ≥18 years
- Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
- Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
- people of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
- Signed and dated informed consent form
- History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
- Positive DAT or IAT at study entry
- Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- Treatment with any medication known to affect RBC viability
- Pregnant or nursing females
- Participation in another treatment clinical study currently or has received an investigational drug within the past 28 days
- Less than three months from receiving an infusion of a radiolabeled blood component.
- Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.
- Non study blood component donation throughout the study
- Preexisting antibody specific to INTERCEPT RBCs
- History of known hypersensitivity to chromium or technetium
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.