In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Condition: Healthy
Intervention: INTERCEPT Treated Platelets
Intervention description: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) will be simultaneously administered intravenously into the subject.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: INTERCEPT; Recovery; Survival; 7 days; Radiolabeled; Autologous

Summary:

      The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets
      in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain
      sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and
      survival of autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma
      will be measured in comparison to "fresh" autologous radiolabeled platelets (Control)
      according to FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol.

      A secondary objective is to compare the recovery and survival results for Test platelets
      prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for
      Safer Transfusion Collaboration (BEST) or a variation of the BEST procedure (referred to as
      Variant 1) in Stage 1 of this study protocol. Cerus has demonstrated that the Variant 1
      method, which does not incorporate an initial soft spin in the presence of ACD A, results in
      improved in vitro platelet recovery and quality during preparation for radiolabeling compared
      to the BEST procedure. This comparison will evaluate the hypothesis that preparation methods
      prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and
      post-infusion viability outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18 years, of either gender.

          -  Normal health status (as determined by the Investigator review of medical history and
             blood donor physical exam).

          -  Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet
             donation. Travel, tattoos/piercings and/or male to male sexual contact deferrals do
             not apply.

          -  Complete blood count (CBC) and serum chemistry values within established reference
             ranges or within guidelines as above.

          -  Pre-donation platelet count of more than 150×10^9 platelets/ L.

          -  Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV.

          -  Subjects of childbearing potential must agree to use a medically acceptable method of
             contraception throughout the study. A barrier method of contraception must be
             included, regardless of other methods.

          -  Signed and dated informed consent form.

        Exclusion Criteria:

          -  For participation in Stage 2, received any previous infusion in this study.

          -  Clinically significant acute or chronic disease (as determined by the Investigator).

          -  Pregnant or nursing females.

          -  Subjects of childbearing potential not using effective contraception.

          -  Disease states or conditions that preclude apheresis platelet donation per AABB
             reference standards.

          -  Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or
             treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents (or
             other drugs affecting platelet viability within 3 days of apheresis (e.g., ibuprofen
             or other NSAIDs).

          -  Subject received platelet inhibitors within 14 days of donation (e.g., clopidogrel,
             ticlopidine, amphetamines (e.g., Adderall, Dexedrine)).

          -  Subjects with positive cocaine and/or amphetamine results from urine drug screen.

          -  Splenectomized subjects.

          -  History of known hypersensitivity to indium or chromium.

          -  Has received an investigational drug within the past 28 days