Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets

Inclusion Criteria:

- Male or female, at least 18 years of age.

- Ability to comprehend the study procedures and signed informed consent.

- If pre-menopausal female, must have a negative serum pregnancy test, and, if of child
bearing potential, must be using an acceptable method of contraception.

- Diagnosed with any the following: acute leukemia (ALL or AML), chronic leukemia (CML,
CLL, CMML, or hairy cell leukemia), myelodysplasia, aplasia, hematopoietic or
non-hematopoietic solid tumor, or therapy (chemotherapy or radiation) induced bone
marrow aplasia or hypoplasia. Either autologous or allogeneic bone marrow transplant
or peripheral or cord blood stem cell recipients may be enrolled.

- WHO grade 2 or greater bleeding.

- LSP transfusion within the previous 48 hours.

Exclusion Criteria:

- Acute or chronic DIC as evidence by D-dimer greater than 8 μg/mL and fibrinogen less
than 100 mg (0.1 g)/dL. Both criteria must be met. If data are in the medical record
for fibrin degradation products (FDPs), then FDP must be <=40 μg/mL (FDP >40 μg/mL is
indicative of DIC).

- PT or aPTT > 1.3 times the upper limit of normal for the laboratory.

- History of major operative procedures that required general anesthesia in the past 2
weeks.

- History of any prior major unprovoked thrombotic events and/or known inherited
disorder of coagulation or platelet function (by history) (not to include clots in
catheters, etc).

- A history or diagnosis of immune thrombocytopenia, thrombotic thrombocytopenic
purpura, or hemolytic uremic syndrome.

- Females who are breastfeeding.

- Veno-occlusive disease or possible veno-occlusive disease.

- Receiving active, inpatient treatment with anti-platelet drugs and/or full
anticoagulation therapy. Note: a heparin flush may be given daily and before and after
blood draws to patients with a central line to keep the line patent.

- Subject previously enrolled in this study and received a study transfusion.