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

NCT ID: NCT00663416

Last Updated: 2009-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

NTx™-265: rhCG, then rEPO

Intervention Type: DRUG

• 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

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: DRUG

• Saline SC, on Day 1, 3, and 5 of study participation, then
• Saline IV, on Day 7, 8, and 9 of study participation

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Ovidrel; Eprex; Sodium Chloride 0.9%

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stem Cell Therapeutics Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Stem Cell Therapeutics Corp.

Principal Investigators

Michael D Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Neurosciences, University of Calgary

Steven C Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Califonia, Irvine Medical Center

Locations

Department of Clinical Neurosciences, Univeristy of Calgary

Calgary, Alberta, Canada

Walter Mackenzie Health Sciences Centre

Edmonton, Alberta, Canada

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Chinook Regional Hospital

Lethbridge, Alberta, Canada

Penticton Regional Hospital

Penticton, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Vancouver Island Health Research Centre

Victoria, British Columbia, Canada

Brandon Regional Health Centre

Brandon, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

McMaster Clinic

Hamilton, Ontario, Canada

Trillium Health Centre

Mississauga, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Division of Neurology , Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Department of Neurology, St. Michael's Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

Department of Neurology, Care Hospital

Hyderabad, Andhra Pradesh, India

Krishna Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India

Department of Neurology, Apollo Hospitals

Hyderabad, Andhra Pradesh, India

Department of Neurology, Nizam's Institute of Medical Science

Hyderabad, Andhra Pradesh, India

M S Ramaiah Memorial Hospital

Bangalore, Karnataka, India

Max Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, India

Christian Medical College & Hospital

Ludhiana, Punjab, India

Department of Neurology, Christian Medical College

Vellore, Tamil Nadu, India

AMRI Hospital

Kolkata, West Bengal, India

Department of Neurology, B.P.Poddar Hospital & Medical Research Ltd

Kolkata, West Bengal, India

Countries

Canada; India

Other Identifiers

NTx™-265-CP-201-IS (CA)

Identifier Type: -

Identifier Source: org_study_id