A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
The objective of this study is to test the hypothesis that INTERCEPT Blood System for
 platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain
 sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of
 autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test
 platelets) stored for 6 or 7 days will be measured in comparison to "fresh" autologous
 radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing
 (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will
 also be assessed.
For each of the 2 study donation periods, this study will have the following procedures:
 single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT
 Blood System treatment, storage for 6 or 7 days (depending on the period and randomization
 scheme) at 20°C to 24°C with agitation, collection of "fresh" autologous platelets,
 radiolabeling, infusion of fresh and stored INTERCEPT Blood System-treated radiolabeled
 autologous platelets, and collection of blood samples for assessment of platelet recovery and
 survival (lifespan). There will be a minimum wash-out period of two weeks between the two
 study periods.

 Apheresis platelets will be collected using the Amicus separator and stored for 6 or 7 days
 (depending on the period and randomization scheme) in 35% plasma/65% InterSol.

 Procedures will be as follows: On Day 0, each healthy volunteer subject has apheresis
 platelets collected. INTERCEPT Blood System treatment will begin on either the day of
 donation (Day 0) or the day following donation (Day 1) and will be completed within 24 hours
 after collection. Platelets will then be stored for 6 or 7 days after collection (depending
 on the period and randomization scheme) at 22°C ±2°C with agitation. Aliquots for in vitro
 platelet function will be taken on Day 0/1 before INTERCEPT Blood System treatment and on Day
 6 or 7. On Day 6 or 7, healthy volunteers will return to the site, and 43 mL of blood will be
 drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A
 (ACD-A). Fresh platelets will be prepared from this sample. An aliquot (10-20 mL) of the
 stored INTERCEPT Blood System for platelets will be aseptically removed from each subject's
 test container.

 Previously stored (Test) and fresh (Control) platelets will be radiolabeled according to
 randomization assignment with either Chromium-51 (51Cr) (≤20 μCi) as sodium radiochromate
 (Na251CrO4) or Indium-111 (111In) (≤15 μCi) as indium oxine, following the labeling and
 washing procedures outlined by the Biomedical Excellence for Safer Transfusion (BEST)
 Collaborative. The isotope labels will be assigned randomly with equal probability that fresh
 platelets and stored INTERCEPT Blood System for platelets will be labeled with each isotope.,
 and the same randomization assignment of isotope labels will be utilized for both donation
 periods for the same subject. Aliquots of the fresh and stored platelets will be radiolabeled
 in tubes with the standard techniques. After radiolabeling, the autologous fresh and stored
 INTERCEPT Blood System for platelets will be simultaneously infused into the subject
 (approximately 10-30 mL). Negative pregnancy test for females of childbearing potential are
 required before infusion.

 Blood samples for radioactivity measurements will be drawn immediately before infusion and at
 approximately 0, 0.5, 1, and 2 hours post-infusion, and then 6 more samples will be drawn at
 1, 2, 3, 4 (or 6), 7, and 11±1 days post-infusion, at approximately the same time of day as
 the radiolabeled platelet infusion was administered (±4 hours).

 Patients will be monitored for safety (adverse events) from the beginning of the study until
 10 days following the infusion of radiolabelled platelets in period 2.

 Radioactivity measurements Samples will be obtained from the radiolabeled fresh and stored
 INTERCEPT Blood System for platelets before infusion and used as a radioactive standard. By
 measuring the volume infused, the total dose of radioactivity infused will be calculated. In
 vitro elution of the label from the transfused platelets will be determined by the BEST
 elution assessment method, as well as the in vivo elution of radioactivity from the serial
 blood samples obtained post-infusion of the labeled platelets.

 The standard as well as the subject's whole-blood samples will be corrected for elution and
 also for the residual activity in the cellular fraction one day after the infusion. Data
 points 24 hours post-infusion will be used to calculate in vivo recovery after all
 radioactive corrections have been made. The radioactivity of the samples will be determined
 by use of a gamma counter. A multiple-hit model will be used to estimate the survival of the
 radioactively labeled platelets.
Inclusion Criteria:

 -  Normal health status (as determined by the Investigator review of medical history and
 blood donor physical exam)

 -  Meet FDA, American Association of Blood Banks (AABB), and site guidelines for blood
 donation or apheresis platelet donation

 -  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 Human Immunodeficiency virus (HIV),
 Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-Lymphotropic virus (HTLV),
 syphilis, and West Nile virus (WNV)

 -  Male and female 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:

 -  Clinically significant acute or chronic disease (as determined by the Investigator)

 -  Pregnant or nursing females

 -  Male or female subjects of childbearing potential not using effective contraception

 -  Disease states or conditions that preclude blood donation or 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 inhibitor within 14 days of donation (e.g. clopidogrel,
 ticlopidine)

 -  Splenectomized subjects

 -  History of known hypersensitivity to indium or chromium

 -  Participation in another clinical study currently or within the past 28 days