CTRI/2009/091/001017
Completed
Phase 2
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
Stem Cell Therapeutics Corp. Suite 1000, 1520-4th St. SW Calgary, Alberta, Canada T2R 1H50 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stem Cell Therapeutics Corp. Suite 1000, 1520-4th St. SW Calgary, Alberta, Canada T2R 1H5
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 18\-85
- •2\.NIHSS score 8\-20
- •3\.Stroke is ischemic in origin, supratentorial, and radiologically confirmed
- •4\.Patient is 24\-48 hours from time of stroke onset when the first dose of NTx®\-265 therapy is administered
- •5\.Reasonable expectation of availability to receive the full 9 day NTx®\- 265 therapy and 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 not of childbearing potential or agrees to use two of the effective separate forms of contraception throughout the study
Exclusion Criteria
- •1\.Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- •2\.Patients who have received thrombolytic treatment with tPA following the index stroke
- •3\.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\)
- •4\.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
- •5\.Blood hemoglobin \> 16 g/dL (males) or \> 14 g/dL (females); or platelet count \> 400,000/mm3
- •6\.Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
- •7\.Serum bilirubin \> 1\.5 x ULN
- •8\.Alkaline phosphatase \> 2\.5 x ULN
- •9\.AST or ALT \> 2\.5 x ULN
- •10\.Creatinine \> 2\.0 x ULN
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 2
A Clinical Study of NTx-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patientsCTRI/2008/091/000262Stem Cell Therapeutics Corp
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A Clinical Study of NTx®-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patientsHealth Condition 1: null- Acute ischemic strokeCTRI/2009/091/000468Stem Cell Therapeutics Corp
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