Clinical trial NCT00362414: Beta-hCG + Erythropoietin in Acute Stroke
Official title: Safety of Beta-hCG + Erythropoietin in Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Stroke
Keywords: Stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Stem Cell Therapeutics Corp.
name: Hoag Memorial Hospital Presbyterian
First posted: 2006-08-10
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.

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.

Primary outcomes:
measure: Safety
timeFrame: 3 mo
measure: Morbidity
timeFrame: 3 mo
measure: Mortality
timeFrame: 3 mo
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: 3 mo
measure: Fugl-Meyer Arm Scale
timeFrame: 3 mo
measure: Fugl-Meyer Leg Scale
timeFrame: 3 mo.
measure: Boston Naming Test
timeFrame: 3 mo
measure: Line Cancellation Test
timeFrame: 3 mo
measure: NIH Stroke Scale
timeFrame: 3 mo
measure: Geriatric Depression Scale Short Form
timeFrame: 3 mo
measure: Barthel Index
timeFrame: 3 mo
measure: Infarct Volume Using Anatomical MRI
timeFrame: 3 mo
measure: Trail Making A Test
timeFrame: 3 mo
measure: Trail Making B Test
timeFrame: 3 mo.
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Steven C. Cramer, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: