Thrombosomes® in Bleeding Thrombocytopenic Patients

The objectives of this trial, conducted in thrombocytopenic patients with modified World
Health Organization (WHO) Grade 1* or 2 bleeding, assessing the safety of infusing increasing
doses of allogeneic Thrombosomes in WHO bleeding and measures of coagulation.

Inclusion Criteria:

- Adults up to 68 y/o with any of following: acute leukemia (ALL or AML),
myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone
marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤
70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral
or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.

- Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with
Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4
weeks of screening. The Grade 1 subset includes patients who have either epistaxis,
hematuria, oral petechiae, or bleeding at invasive or other wound sites.

- No platelet inhibitor drugs within 5 days prior to infusion and during the immediate
study 6 Day follow-up period.

Exclusion Criteria:

- Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia,
including but not limited to: TIA, stroke, MI, stent placement, valve replacement
and/or repair

- Currently with an active acute infection, or suspected infection, a single oral
temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in
past 24 h. Subjects on prophylactic antibiotics are not excluded from study

- Coagulopathy or receiving anticoagulants that result in PT or aPTT values greater than
1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen

- History of any inherited coagulation or platelet function, disorder or ITP, TTP, or
HUS

- Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion

- Rx with an investigational drug w/in 1 month of infusion, other than for treatment of
their underlying disease