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Clinical Trials/CTRI/2009/091/000468
CTRI/2009/091/000468
Recruiting
Phase 2

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

Stem Cell Therapeutics Corp0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- Acute ischemic stroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: null- Acute ischemic stroke
Sponsor
Stem Cell Therapeutics Corp
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Age 18\-85\.
  • •2\. NIHSS score 8\-20 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.
  • •4\. 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.
  • •5\. Reasonable expectation of availability to receive the full 9 day NTx®\-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 (IUD)contraceptives (e.g. implants, injectables, combined oral, etc.)

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\. Serum 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): Appendix I
  • •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 patients
CTRI/2008/091/000262Stem Cell Therapeutics Corp
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