A Phase IIb prospective, randomized, double-blind, placebo controlled study of NTxTM-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients (REGENESIS)

Stem Cell Therapeutics Corp0 sites0 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\. Age 18\-85\.
•2\. NIHSS score 6\-24 within 24\-48 hours after stroke onset and enrolment.
•3\. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment. MRI is mandatory for patients included in the MRI sub\-study.
•4\. 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.
•5\. Reasonable expectation of availability to receive the full 9 day NTxTM\-265 course of therapy, and to be available for subsequent follow\-up visits.
•6\. Reasonable expectation that patient will receive standard post\-stroke physical, occupational, speech, and cognitive therapy as indicated.
•7\. Female patient is either:
•a. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
•b. 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)

•1\. Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
•2\. 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\).
•3\. 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.
•4\. Serum hemoglobin \> 16 g/dL (males) or \> 14 g/dL (females). Platelet count \> 400,000/mm3\.
•5\. Advanced liver, kidney, cardiac and/or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher): Appendix II
•6\. Serum bilirubin \> 1\.5 x upper limit of normal (ULN)
•7\. Alkaline phosphatase \> 2\.5 x ULN
•8\. AST \> 2\.5 x ULN, ALT \> 2\.5 x ULN
•9\. Creatinine \> 2\.0 x ULN
•10\. Patients with known and documented transferrin saturation \< 20%. Patients with known and documented Ferritin \< 100 ng/mL.

Not specified