REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

This study has been terminated.
Sponsor:
Information provided by:
Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier:
NCT00663416
First received: April 18, 2008
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: NTx™-265: rhCG, then rEPO
Drug: Saline placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Stem Cell Therapeutics Corp.:

Primary Outcome Measures:
  • Modified Rankin Score (mRS) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • NIHSS response [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIHSS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Action Research Arm Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Gait Velocity Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Boston Naming Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Line Cancellation Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Trails A & B Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: March 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: NTx™-265: rhCG, then rEPO
  • rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then
  • rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation
Other Names:
  • Ovidrel
  • Eprex
Placebo Comparator: 2 Drug: Saline placebo
  • Saline SC, on Day 1, 3, and 5 of study participation, then
  • Saline IV, on Day 7, 8, and 9 of study participation
Other Name: Sodium Chloride 0.9%

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
    2. 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:

    1. Prior hypersensitivity to hCG preparations or one of their excipients.
    2. Primary ovarian failure.
    3. Uncontrolled thyroid or adrenal dysfunction.
    4. An uncontrolled organic intracranial lesion such as a pituitary tumor.
    5. Abnormal uterine bleeding of undetermined origin.
    6. Ovarian cyst or ovarian enlargement of undetermined origin.
    7. Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
  • Allergy or other contraindication to epoetin alfa:

    1. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
    2. With uncontrolled hypertension
    3. With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
    4. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663416

Locations
Canada, Alberta
Department of Clinical Neurosciences, Univeristy of Calgary
Calgary, Alberta, Canada, T2N 2T9
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X3
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Chinook Regional Hospital
Lethbridge, Alberta, Canada, T1J 1W5
Canada, British Columbia
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver Island Health Research Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
Brandon Regional Health Centre
Brandon, Manitoba, Canada, R7A 2B3
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster Clinic
Hamilton, Ontario, Canada, L8L 2X2
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Department of Neurology, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Division of Neurology , Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
India
Department of Neurology, Apollo Hospitals
Hyderabad, Andhra Pradesh, India, 500033
Department of Neurology, Nizam's Institute of Medical Science
Hyderabad, Andhra Pradesh, India, 500082
Krishna Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500003
Department of Neurology, Care Hospital
Hyderabad, Andhra Pradesh, India, 500001
Max Super Speciality Hospital
New Delhi, Delhi, India, 110017
M S Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
Christian Medical College & Hospital
Ludhiana, Punjab, India, 141008
Department of Neurology, Christian Medical College
Vellore, Tamilnadu, India, 632004
AMRI Hospital
Kolkata, West Bengal, India, 700029
Department of Neurology, B.P.Poddar Hospital & Medical Research Ltd
Kolkata, West Bengal, India, 700053
Sponsors and Collaborators
Stem Cell Therapeutics Corp.
Investigators
Principal Investigator: Michael D Hill, MD Department of Clinical Neurosciences, University of Calgary
Principal Investigator: Steven C Cramer, MD Department of Neurology, University of Califonia, Irvine Medical Center
  More Information

No publications provided

Responsible Party: Alan Moore / President & Chief Executive Officer, Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier: NCT00663416     History of Changes
Other Study ID Numbers: NTx™-265-CP-201-IS (CA)
Study First Received: April 18, 2008
Last Updated: August 10, 2009
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee
India: Drugs Controller General of India
India: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Chorionic Gonadotropin
Epoetin Alfa
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 28, 2014