Status:
TERMINATED
REGENESIS (CA): A 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
Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control. Secondary objective: To assess the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 NTxTM-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 NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
- Reasonable expectation that patient will receive standard post-stroke physical, occupational and speech therapy as indicated.
- Female patient is either:
- Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (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:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR
- A vasectomised partner OR
- Abstinence
- Exclusion Criteria
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke.
- Patients who have received thrombolytic treatment with tPA following the index stroke.
- Patients classified as comatose, defined as a patient who required 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 upper limit of normal (ULN).
- Alkaline phosphatase \> 2.5 x ULN.
- AST\>2.5xULN.
- ALT \> 2.5 x ULN.
- Creatinine \> 2.0 x ULN.
- Patients with known and documented transferrin saturation \< 20%.
- Patients with known and documented ferritin \< 100 ng/mL.
- Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
- Patients with a known or current history of abnormal hypercoagulability parameters , including known cardiolipin/antiphospholipid antibody syndrome.
- Expected survival \< 1 year.
- Allergy or other contraindication to hCG including:
- Prior hypersensitivity to hCG preparations or one of their excipients.
- Primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An uncontrolled organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin.
- Ovarian cyst or ovarian enlargement of undetermined origin.
- Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
- Allergy or other contraindication to epoetin alfa:
- Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
- With uncontrolled hypertension
- With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
- Who for any reason cannot receive adequate antithrombotic treatment
- 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 6 months.
- Patients who cannot take anti-platelet therapy for the duration of the study.
- Patients who cannot take low molecular weight or unfractionated heparin during hospitalization.
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00663416
Start Date
March 1 2008
End Date
January 1 2009
Last Update
August 12 2009
Active Locations (26)
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1
Department of Clinical Neurosciences, Univeristy of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
3
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X3
4
Chinook Regional Hospital
Lethbridge, Alberta, Canada, T1J 1W5