REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

Exclusion Criteria

• •Patients presenting with lacunar, hemorrhagic and/or brain stem stroke.
• •Patients who have received thrombolytic treatment with tPA following the index stroke.
• •Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be \<2)
• •Women who have tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
• •Serum hemoglobin \> 16 g/dL (males) or \> 14 g/dL (females); or platelet count \> 400,000/mm3.
• •Advanced liver,kidney, cardiac or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
• •Serum bilirubin \> 1.5 x upper limit of normal (ULN).
• •Alkaline phosphatase \> 2.5 x ULN.
• •AST\>2.5xULN.
• •ALT \> 2.5 x ULN.
• •Creatinine \> 2.0 x ULN.
• •Patients with known and documented transferrin saturation \< 20%.
• •Patients with known and documented ferritin \< 100 ng/mL.
• •Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
• •Patients with a known or current history of abnormal hypercoagulability parameters , including known cardiolipin/antiphospholipid antibody syndrome.
• •Expected survival \< 1 year.
• •Allergy or other contraindication to hCG including:
• •1. Prior hypersensitivity to hCG preparations or one of their excipients.
• •2. Primary ovarian failure.
• •3. Uncontrolled thyroid or adrenal dysfunction.
• •4. An uncontrolled organic intracranial lesion such as a pituitary tumor.
• •5. Abnormal uterine bleeding of undetermined origin.
• •6. Ovarian cyst or ovarian enlargement of undetermined origin.
• •7. Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
• •Allergy or other contraindication to epoetin alfa:
• •1. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
• •2. With uncontrolled hypertension
• •3. With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
• •4. Who for any reason cannot receive adequate antithrombotic treatment
• •A known diagnosis of cancer (except non-malignant skin cancer).
• •Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.
• •Use of either hCG or epoetin alfa within the previous 90 days.
• •Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor.
• •Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2.
• •Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
• •Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial.
• •With the exception of the qualifying stroke, any other stroke within the previous 6 months.
• •Patients who cannot take anti-platelet therapy for the duration of the study.
• •Patients who cannot take low molecular weight or unfractionated heparin during hospitalization.
• •Pre-existing and active major psychiatric or other chronic neurological disease.
• •Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependency within 12 months prior to the study.
• •Currently participating in another investigational study.