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REGENESIS (US): 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)

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ClinicalTrials.gov Identifier: NCT00715364
Recruitment Status : Withdrawn
First Posted : July 15, 2008
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
Stem Cell Therapeutics Corp.

Brief Summary:

To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.

To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.


Condition or disease Intervention/treatment Phase
Stroke Drug: NTx™-265: rhCG, then rEPO Drug: Saline Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Study Start Date : August 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: NTx™-265: rhCG, then rEPO
  • rhCG 385 µg, 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
  • Epogen

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%




Primary Outcome Measures :
  1. Adverse events [ Time Frame: screening to Day 90 ]

Secondary Outcome Measures :
  1. mRS [ Time Frame: Day 90 ]
  2. NIHSS [ Time Frame: Day 90 ]
  3. Barthel Index [ Time Frame: Day 90 ]
  4. Action Research Arm Test [ Time Frame: Day 90 ]
  5. Gait Velocity Test [ Time Frame: Day 90 ]
  6. Boston Naming Test [ Time Frame: Day 90 ]
  7. Line Cancellation Test [ Time Frame: Day 90 ]
  8. Trails A & B Test [ Time Frame: Day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 tubal ligation, 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 (IUD) contraceptives (e.g. implants, injectables, combined oral, etc.) OR ii) a vasectomized 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 requires 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 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
  • Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
  • Expected survival < 1 year
  • Allergy or other contraindication to hCG
  • 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 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715364


Locations
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United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
University of California, Irvine Medical Center
Orange, California, United States, 92868-4280
Sponsors and Collaborators
Stem Cell Therapeutics Corp.
Investigators
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Principal Investigator: Steven C Cramer, MD, MMSc Department of Neurology, University of Califonia, Irvine Medical Center

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Responsible Party: Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier: NCT00715364     History of Changes
Other Study ID Numbers: NTx™-265-CP-201-IS (US)
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Epoetin Alfa
Chorionic Gonadotropin
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematinics
Reproductive Control Agents
Physiological Effects of Drugs