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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00715364

Run by

Stem Cell Therapeutics Corp.

People needed

30

Starts

2009-08-01

Expected to finish

2010-09-01

Last updated by the study team

2011-09-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
• 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

You may not qualify if…

• 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

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• University of California, Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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