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 1H520 个研究点分布在 1 个国家目标入组 0 人开始时间: 待定

试验速览

阶段: 2 期
发起方
试验地点: 20
主要终点: Modified Rankin Score (mRS) NIHSS response

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The proposed study is a phase IIb, multi-center, randomized, double-blind placebo controlled study. It is being conducted at multiple sites in Canada, USA and India. The total sample size is 128 patients. In India, the study is proposed to be conducted at fifteen (15) investigative sites to recruit approximately 90 patients. The anticipated date of enrollment in India is 07 August 2009. The purpose of this study is to determine the safety and efficacy of the NTx®-265 (Human Chorionic Gonadotropin and Epoetin alfa) therapy in acute ischemic stroke patients over placebo.

研究设计

分配方式: Stratified randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

入选标准

•1.Age 18-852.NIHSS score 8-203.Stroke is ischemic in origin, supratentorial, and radiologically confirmed4.Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered5.Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits6.Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated7.Female patient is either not of childbearing potential or agrees to use two of the effective separate forms of contraception throughout the study.

排除标准

•1.Patients presenting with lacunar, hemorrhagic and/or brain stem stroke2.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 study5.Blood hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm36.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 ULN8.Alkaline phosphatase > 2.5 x ULN9.AST or ALT > 2.5 x ULN10.Creatinine > 2.0 x ULN11.Patients with known and documented elevated PSA levels12.Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome13.Expected survival < 1 year14.Allergy or other contraindication to hCG including:a.Prior hypersensitivity to hCG preparations or one of their excipientsb.Primary ovarian failurec.Uncontrolled thyroid or adrenal dysfunctiond.An uncontrolled organic intracranial lesion such as a pituitary tumore.Abnormal uterine bleeding of undetermined originf.Ovarian cyst or ovarian enlargement of undetermined origing.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 hormonesb.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 therapy18.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 tumor20.Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 221.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 dressing22.Any other medical condition or degree of stroke such that, in the investigator?s opinion, the patient should not be included in the trial23.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 therapy25.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
•Currently participating in another investigational study.

结局指标

主要结局

Modified Rankin Score (mRS) NIHSS response

时间窗: Day 90

次要结局

Barthel Index, Action Research Arm Test, Gait Velocity Test, Boston Naming Test, Line cancellation test, Trails A & B test, Geriatric Depression Scale(day 90)

研究者

发起方

Stem Cell Therapeutics Corp. Suite 1000, 1520-4th St. SW Calgary, Alberta, Canada T2R 1H5

研究点 (20)

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