Status:
UNKNOWN
Recovery and Lifespan of Red Blood Cells From Pathogen-reduced, Stored Blood Units
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Cerus Corporation
Biomedical Advanced Research and Development Authority
Conditions:
Red Cell Survival in Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC by measuring the 24 hour post-infusion recovery ("PTR24") and lifespan of autologous RBCs prepared with th...
Detailed Description
Each subject will receive one infusion of autologous, radiolabeled and BioRBC labeled INTERCEPT RBCs (Test RBCs) and one infusion of autologous BioRBC labeled untreated RBCs (Control RBCs) concomitant...
Eligibility Criteria
Inclusion
- Subject Inclusion Criteria
- Up to 12 subjects will be enrolled for a maximum of 6 eligible subjects in the pilot study to provide preliminary RBC survival data to support a subsequent adequately powered study capable of addressing the two objectives as stated above.
- Age ≥18 years, of either gender
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Weight over 140 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). Values outside of normal reference range if considered not to be clinically significant may be allowed with a protocol exception.
- Minimum hemoglobin levels of 13 g/dL for female and 14 g/dL for male subjects
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, WNV and Zika virus
- 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).
- Signed and dated informed consent form
- Subject Exclusion Criteria
- Clinically significant acute or chronic disease (as determined by the Investigator)
- History of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies or autoimmune disease
- History of congenital red cell disorders including glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Positive Direct (DAT) and Indirect antiglobulin test (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 female
- Male subjects or female subjects of childbearing potential not using effective contraception
- Participation in another clinical study currently or within the past 28 days
- Prior exposure to INTERCEPT treated or BioRBCs
- Pre-existing antibody specific to INTERCEPT RBCs or BioRBC
- Subjects are excluded if receiving immunosuppressive therapies (e.g., oral or intravenous corticosteroids) due to their potential to obscure immunogenicity or immunoreactivity to Test RBCs.
- Subjects donating blood for any other purpose
- Subjects who have received blood transfusion within the previous year
- Subjects who are enrolled in another study.
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03384407
Start Date
January 1 2019
End Date
December 31 2019
Last Update
January 9 2019
Active Locations (1)
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1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267