Status:
WITHDRAWN
REGENESIS (US): A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Lead Sponsor:
Stem Cell Therapeutics Corp.
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients. To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compar...
Eligibility Criteria
Inclusion
- Age 18-85.
- NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
- Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
- Patient is 24-48 hours from time of stroke onset when the first dose of NTx™-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
- Reasonable expectation of availability to receive the full 9 day NTx™-265 course of therapy, and to be available for 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, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
- if of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow up visits: i) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (e.g. implants, injectables, combined oral, etc.) OR ii) a vasectomized partner OR iii) abstinence
Exclusion
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- Patients classified as comatose, defined as a patient who requires 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 ULN
- Alkaline phosphatase \> 2.5 x ULN
- AST or ALT \> 2.5 x ULN
- Creatinine \> 2.0 x ULN
- Patients with known and documented Transferrin saturation \<20% or ferritin \< 100 ng/ml
- Patients with known and documented elevated PSA levels
- Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
- Expected survival \< 1 year
- Allergy or other contraindication to hCG
- Allergy or other contraindication to epoetin alfa:
- 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 3 months
- Patients who cannot take anti-platelet or anti-coagulant therapy
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00715364
Start Date
August 1 2009
End Date
September 1 2010
Last Update
September 5 2011
Active Locations (2)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
2
University of California, Irvine Medical Center
Orange, California, United States, 92868-4280