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

Sponsor
Stem Cell Therapeutics Corp. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00663416
Collaborator
(none)
134
Enrollment
26
Locations
2
Arms
10.1
Duration (Months)
5.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: NTx™-265: rhCG, then rEPO
  • Drug: Saline placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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)
Study Start Date :
Mar 1, 2008
Anticipated Primary Completion Date :
Oct 1, 2008
Anticipated Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Sodium Chloride 0.9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rankin Score (mRS) [Day 90]

    2. NIHSS response [Day 90]

    Secondary Outcome Measures

    1. NIHSS [Day 90]

    2. mRS [Day 90]

    3. Barthel Index [Day 90]

    4. Action Research Arm Test [Day 90]

    5. Gait Velocity Test [Day 90]

    6. Boston Naming Test [Day 90]

    7. Line Cancellation Test [Day 90]

    8. Trails A & B Test [Day 90]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Neurosciences, Univeristy of Calgary Calgary Alberta Canada T2N 2T9
    2 Walter Mackenzie Health Sciences Centre Edmonton Alberta Canada T6G 2B7
    3 Grey Nuns Community Hospital Edmonton Alberta Canada T6L 5X3
    4 Chinook Regional Hospital Lethbridge Alberta Canada T1J 1W5
    5 Penticton Regional Hospital Penticton British Columbia Canada V2A 3G6
    6 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    7 Vancouver Island Health Research Centre Victoria British Columbia Canada V8R 1J8
    8 Brandon Regional Health Centre Brandon Manitoba Canada R7A 2B3
    9 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H 3A7
    10 McMaster Clinic Hamilton Ontario Canada L8L 2X2
    11 Trillium Health Centre Mississauga Ontario Canada L5B 1B8
    12 Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario Canada P7B 6V4
    13 Division of Neurology , Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    14 Department of Neurology, St. Michael's Hospital Toronto Ontario Canada M5B 1W8
    15 University Health Network Toronto Ontario Canada M5T 2S8
    16 Montreal Neurological Institute Montreal Quebec Canada H3A 2B4
    17 Department of Neurology, Care Hospital Hyderabad Andhra Pradesh India 500001
    18 Krishna Institute of Medical Sciences Hyderabad Andhra Pradesh India 500003
    19 Department of Neurology, Apollo Hospitals Hyderabad Andhra Pradesh India 500033
    20 Department of Neurology, Nizam's Institute of Medical Science Hyderabad Andhra Pradesh India 500082
    21 Max Super Speciality Hospital New Delhi Delhi India 110017
    22 M S Ramaiah Memorial Hospital Bangalore Karnataka India 560054
    23 Christian Medical College & Hospital Ludhiana Punjab India 141008
    24 Department of Neurology, Christian Medical College Vellore Tamilnadu India 632004
    25 AMRI Hospital Kolkata West Bengal India 700029
    26 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00663416
    Other Study ID Numbers:
    • NTx™-265-CP-201-IS (CA)
    First Posted:
    Apr 22, 2008
    Last Update Posted:
    Aug 12, 2009
    Last Verified:
    Aug 1, 2009
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Aug 12, 2009