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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

NCT00715364 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-09-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

NTx™-265: rhCG, then rEPO

* rhCG 385 µg, 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

  • Steven C Cramer, MD, MMSc · 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
2009-08-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

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 NCT00715364 on ClinicalTrials.gov