CTRI/2009/091/001017CompletedPhase 2
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
Stem Cell Therapeutics Corp. Suite 1000, 1520-4th St. SW Calgary, Alberta, Canada T2R 1H50 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Age 18-85
- •2.NIHSS score 8-20
- •3.Stroke is ischemic in origin, supratentorial, and radiologically confirmed
- •4.Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
- •5.Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
- •6.Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
- •7.Female patient is either not of childbearing potential or agrees to use two of the effective separate forms of contraception throughout the study
Exclusion Criteria
- •1.Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- •2.Patients who have received thrombolytic treatment with tPA following the index stroke
- •3.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)
- •4.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
- •5.Blood hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3
- •6.Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
- •7.Serum bilirubin > 1.5 x ULN
- •8.Alkaline phosphatase > 2.5 x ULN
- •9.AST or ALT > 2.5 x ULN
- •10.Creatinine > 2.0 x ULN
- •11.Patients with known and documented elevated PSA levels
- •12.Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
- •13.Expected survival < 1 year
- •14.Allergy or other contraindication to hCG including:
- •a.Prior hypersensitivity to hCG preparations or one of their excipients
- •b.Primary ovarian failure
- •c.Uncontrolled thyroid or adrenal dysfunction
- •d.An uncontrolled organic intracranial lesion such as a pituitary tumor
- •e.Abnormal uterine bleeding of undetermined origin
- •f.Ovarian cyst or ovarian enlargement of undetermined origin
- •g.Sex hormone dependent tumors of the reproductive organs, accessory sex glands, or breast(s)
- •15.Allergy or other contraindication to epoetin alfa including patients:
- •a.Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
- •b.With uncontrolled hypertension
- •c.With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
- •d.Who for any reason cannot receive adequate antithrombotic treatment
- •16.A known diagnosis of cancer in the previous 5 years (except non-malignant skin cancer)
- •17.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
- •18.Use of either hCG or epoetin alfa within the previous 90 days
- •19.Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
- •20.Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2
- •21.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
- •22.Any other medical condition or degree of stroke such that, in the investigator?s opinion, the patient should not be included in the trial
- •23.With the exception of the qualifying stroke, any other stroke within the previous 3 months (Patients with asymptomatic stroke can be included if they meet the criteria described in Section 7.4.1)
- •24.Patients who cannot take anti-platelet or anti-coagulant therapy
- •25.Pre-existing and active major psychiatric or other chronic neurological disease
- •26.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
- •27. Currently participating in another investigational study
Investigators
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