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REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

NCT00663416 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2009-08-12

No results posted yet for this study

Summary

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

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

Conditions

Interventions

DRUG

NTx™-265: rhCG, then rEPO

* rhCG 10,000 IU, 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

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

Sponsors & Collaborators

  • Stem Cell Therapeutics Corp.

    lead INDUSTRY

Principal Investigators

  • Michael D Hill, MD · Department of Clinical Neurosciences, University of Calgary

  • Steven C Cramer, MD · Department of Neurology, University of Califonia, Irvine Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2009-01-31

Countries

  • Canada
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663416 on ClinicalTrials.gov