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REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
This study is ongoing, but not recruiting participants.
Sponsored by: Stem Cell Therapeutics Corp.
Information provided by: Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier: NCT00663416
  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 II

Drug Information available for: Epoetin alfa Erythropoietin Chorionic gonadotropin Choriogonadotropin Alfa Sodium chloride Chlorides
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Prospective, Randomized, Double-Blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS)

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
1: Experimental 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
2: Placebo Comparator 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

  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 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.
  • Reasonable expectation of availability to receive the full 9 day NTx™-265 course of therapy, and to be available for subsequent follow-up visits.
  • Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive 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: i). Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR ii). A vasectomised partner OR iii). Abstinence

Exclusion Criteria:

  • Patients presenting with lacunar, hemorrhagic and/or brain stem 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 or ALT > 2.5 x ULN.
  • Creatinine > 2.0 x ULN.
  • Patients with known and documented transferrin saturation < 20% or 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 history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome.
  • Expected survival < 1 year.
  • Allergy or other contraindication to hCG including:
  • Allergy or other contraindication to epoetin alfa:
  • 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 or anti-coagulant therapy.
  • 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
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
Chinook Regional Hospital
Lethbridge, Alberta, Canada, T1J 1W5
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X3
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver Island Health Research Centre
Victoria, British Columbia, Canada, V8R 1J8
Penticton Regional Hospital
penticton, British Columbia, Canada, V2A 3G6
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
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Division of Neurology , Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Department of Neurology, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
McMaster Clinic
Hamilton, Ontario, Canada, L8L 2X2
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
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

Responsible Party: Stem Cell Therapeutics Corp. ( Alan Moore / President & Chief Executive Officer )
Study ID Numbers: NTx™-265-CP-201-IS (CA)
Study First Received: April 18, 2008
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00663416  
Health Authority: Canada: Health Canada;   Canada: Ethics Review Committee

Study placed in the following topic categories:
Epoetin Alfa
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Chorionic Gonadotropin
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs
Nervous System Diseases
Cardiovascular Diseases
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009