Beta-hCG + Erythropoietin in Acute Stroke
Condition: Acute Stroke
MeSH terms: Stroke
Intervention: Dual Growth Factor
Intervention description: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
Intervention MeSH terms: Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Stroke

Summary:

      The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients
      with acute ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21-85

          2. NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor
             devastating

          3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed

          4. Patient is 24-48 hours from time of stroke onset at time that first dose of B-E
             therapy is administered. Time of onset is when symptoms began, and stroke occurred
             during sleep, time of onset is when patient was last seen to be normal.

          5. Reasonable expectation of availability to receive the full 9 day B-E therapy course

          6. Reasonable expectation that patient will receive standard post-stroke physical,
             occupational, speech, and cognitive therapy as indicated

        Exclusion Criteria:

          1. Pre-existing and active major psychiatric or other neurological disease

          2. History of significant alcohol or drug abuse in the prior 3 years

          3. Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a
             platelet count > 400,000/mm3 in either a male or female patient

          4. Advanced liver, kidney, cardiac, or pulmonary disease; the former will be
             operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L,
             SGOT > 150 U/L, SGPT >150 U/L, or creatinine > 3.5 mg/dL

          5. Pregnancy or lactating; note that a negative pregnancy test will be required if the
             patient is a female in reproductive years, using a test that reliably detects beta-hCG
             levels > 25 with normal levels being < 8 IU/L.

          6. Contraindication to study participation on the basis of any of the following:

               1. Allergy or other contraindication to initiating either beta-hCG or Erythropoietin

               2. Known hypersensitivity to mammalian cell-derived products or hypersensitivity to
                  albumin

               3. A known diagnosis of prostatic cancer; note that prostate specific antigen will
                  be collected for retrospective assessment of safety, but will not be used to
                  ascertain study eligibility

               4. Dysuria of unexplained origin

               5. Uncontrolled hypertension, defined in the context of acute stroke as blood
                  pressure persistently above 220 mm Hg systolic or 120 diastolic despite
                  antihypertensive therapy

          7. Current use of either beta-hCG or Erythropoietin

          8. Other condition known to elevate beta-hCG, active in the prior 24 months, e.g.,
             choriocarcinoma or germ cell tumor

          9. Terminal medical diagnosis consistent with survival < 1 year

         10. Known hypercoagulable state, which for the purposes of this study will deficiency of
             proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene
             mutation; or an anti-phospholipid antibody syndrome as based on clinical and
             laboratory measures.