Status:
COMPLETED
Beta-hCG + Erythropoietin in Acute Stroke
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Stem Cell Therapeutics Corp.
Hoag Memorial Hospital Presbyterian
Conditions:
Acute Stroke
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.
Detailed Description
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke...
Eligibility Criteria
Inclusion
- Age 21-85
- NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating
- Stroke is ischemic in origin, supratentorial, and radiologically confirmed
- 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.
- Reasonable expectation of availability to receive the full 9 day B-E therapy course
- Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
Exclusion
- Pre-existing and active major psychiatric or other neurological disease
- History of significant alcohol or drug abuse in the prior 3 years
- 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
- 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
- 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.
- Contraindication to study participation on the basis of any of the following:
- Allergy or other contraindication to initiating either beta-hCG or Erythropoietin
- Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin
- 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
- Dysuria of unexplained origin
- Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy
- Current use of either beta-hCG or Erythropoietin
- Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
- Terminal medical diagnosis consistent with survival \< 1 year
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00362414
Start Date
August 1 2006
End Date
March 1 2008
Last Update
August 29 2016
Active Locations (1)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868-4280