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临床试验/CTRI/2009/091/000468
CTRI/2009/091/000468招募中2 期

A Phase IIb prospective, randomized, double-blind, placebo controlled, dose escalation study of NTx®-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients (REGENESIS-LED)

Stem Cell Therapeutics Corp0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
招募中
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1. Age 18-85.
  • •2. NIHSS score 8-20 within 24-48 hours after stroke onset and enrolment.
  • •3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
  • •4. 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.
  • •5. Reasonable expectation of availability to receive the full 9 day NTx®-265 course of therapy, and to be available for 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 :
  • •a. not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
  • •b. 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 (IUD)contraceptives (e.g. implants, injectables, combined oral, etc.)
  • •? a vasectomized partner
  • •? abstinence

排除标准

  • •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. Serum 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): Appendix I
  • •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, and breasts
  • •15. Allergy or other contraindication to epoetin alfa:
  • •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) &#8805; 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

研究者

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