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

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

• To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.

• To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stem Cell Therapeutics Corp.
• Treatments: Chorionic Gonadotropin; Epoetin Alfa

Criteria

Inclusion Criteria:

• Age 18-85

• NIHSS score 8-20

• Stroke is ischemic in origin, supratentorial, and radiologically confirmed

• Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered

• Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits

• Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated

• Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria:

• Patients presenting with lacunar, hemorrhagic and/or brain stem stroke

• Patients who have received tissue plasminogen activator (tPA)following the index stroke

• Patients classified as comatose

• Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control

• Serum hemoglobin > 16 grams(g)/deciliter (dL)(males) or > 14 g/dL (females); or platelet count > 400,000/cubic millimeters(mm3)

• Advanced liver, kidney, cardiac, or pulmonary disease

• Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels

• Patients with a known history of hypercoagulability

• Expected survival < 1 year

• Allergy or other contraindication to hCG or EPO

• A known diagnosis of cancer in the previous 5 years

• Uncontrolled hypertension

• Use of either hCG or epoetin alfa within the previous 90 days

• Any condition known to elevate hCG

• Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2

• Any patients not living independently

• 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 3 months

• Patients who cannot take anti-platelet or anti-coagulant therapy

• Pre-existing and active major psychiatric or other chronic neurological disease

• Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study

• Currently participating in another investigational study