NCT00663416TerminatedPhase 2
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 (REGENESIS)
Stem Cell Therapeutics Corp.26 sites in 2 countries134 target enrollmentStarted: March 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stem Cell Therapeutics Corp.
- Enrollment
- 134
- Locations
- 26
- Primary Endpoint
- Modified Rankin Score (mRS)
Study Overview
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 safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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/mm
- •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) ≥
- •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.
- +4 more not shown
Exclusion Criteria
- Not provided
Arms & Interventions
2
Placebo Comparator
Intervention: Saline placebo (Drug)
Outcomes
Primary Outcomes
Modified Rankin Score (mRS)
Time Frame: Day 90
NIHSS response
Time Frame: Day 90
Secondary Outcomes
- NIHSS(Day 90)
- mRS(Day 90)
- Barthel Index(Day 90)
- Action Research Arm Test(Day 90)
- Gait Velocity Test(Day 90)
- Boston Naming Test(Day 90)
- Line Cancellation Test(Day 90)
- Trails A & B Test(Day 90)
Investigators
Study Sites (26)
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