Cold Apheresis Platelets in PAS

A single hyperconcentrated apheresis platelet unit will be collected from a healthy adult
volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma
will be collected. The platelet unit will be stored, not-agitated, for up to 20 days at 4°C
in a suspension of 35% plasma and 65% PAS (Platelet Additive Solution).

At the end of the storage period, the subject will return to receive an 111Indium Oxine
(Indium 111, In-111) radiolabeled aliquot of their 4°C stored platelets. Follow-up samples
from the subject will be collected approximately 2 hours post-infusion and on Days 1 (2X), 2
(2X), and 3 to calculate recovery and survival of the subject's 4°C stored platelets. The Day
1 and Day 2 the sample draws will be 2 - 10 hours apart.

In addition to radiolabeled platelet recovery and survival measurements, various in vitro
assays will be performed on the day of collection at the end of 4°C storage.

One week after the infusion of the radiolabeled aliquot, the subject will return to receive a
second radiolabeled aliquot of fresh platelets. To facilitate this, on the morning of the
second infusion, the subject will return for collection of a 43 mL blood sample. The blood
will be processed to obtain a fresh sample of the subject's platelets to serve as a control
comparator. The platelets will be radiolabeled with In-111. The subject will return later in
the day for infusion of the radiolabeled fresh 'control' comparator aliquot. Follow-up blood
samples will be drawn at ~2 hours after the infusion on Day 0 and then on Days 1, 2, 3, 4 or
5, and 6 or 7 day post infusion to calculate recovery and survival of the subject's fresh vs.
stored platelets.

Inclusion Criteria:

- Weight: ≥ 110 pounds

- Platelet count: ≥ 150X10^3/mL

- Hematocrit: 38% for females, 39% for males, but not >55%

- Temperature: ≤ 99.5 F

- Resting blood pressure: systolic ≤180 mmHg; diastolic ≤ 100 mmHg

- Resting heart rate: 40 to 100 beats per minute

- Subjects must be: at least 18 years old, of either sex

- Subjects must be able to read, understand and sign the informed consent document and
commit to the study follow-up schedule. The ability to read and speak English is
required for participation.

- Subjects must have good veins for apheresis platelet collection and drawing blood
samples.

- Subjects of child-bearing potential (either male or female) must agree to use an
effective method of contraception during the course of the study. The following
methods of contraception are be considered effective; abstinence, intrauterine
contraception devices, hormonal methods, barrier methods or history of sterilization.

Exclusion Criteria:

Healthy subjects will be excluded from the study for any of the following reasons:

- Unable to achieve target platelet yield of 3.0 X 1011/unit per Trima Accel (apheresis
machine) configuration parameters.

- Ever received radiation therapy.

- Already participated in 4 research studies involving radioisotopes within the
contemporaneous calendar-year.

- Taken aspirin, non-steroidal anti-inflammatory, or other platelet affecting drugs
within 72 hours of collection or infusion. Subjects who have ever been prescribed
anti-platelet medications (e.g. clopidogrel) will be excluded from study participation
regardless of the interval to their last dose.

- Currently pregnant or nursing as assessed during interview. A urine pregnancy test
prior to radioisotope infusion is required for women of childbearing potential.

- Unable to comply with the protocol in the opinion of the investigator.

- Donated granulocytes within the last 2 days.

- Donated whole blood within the last 7 days.

- Donated platelets or plasma within the last 28 days.