Clinical Trial Details

Overview

Research Study Summary

A Double-Blind, Controlled Phase 2B Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke

Purpose

This study is being conducted to determine the safety and efficacy of stem cells administered by injection into the brain around the area of the stroke.

To Learn more

CW ID: 213739
Date Last Changed: March 23, 2016

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
SanBio
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI
  • Between 6 and 60 months post-stroke, and having a chronic motor neurological deficit
  • Neurological motor deficit substantially due to incident stroke (ie, the stroke that qualified the patient for the study)
  • Modified Rankin Score of 2-4

Exclusion Criteria:

  • History or presence of any other major neurological disease other than stroke
  • Cerebral infarct size >100 cm3 measured by MRI
  • Primary intracerebral hemorrhage
  • Myocardial infarction within prior 6 mos.
  • Malignancy unless in remission >5 yrs.
  • Clinically significant finding on MRI of brain not related to stroke
  • Any seizures in the prior 3 months
  • More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and ankle

Contact

Tara McTigue
University of South Florida - South Tampa Center for Advanced Healthcare
2 Tampa General Circle
Tampa, FL 33606

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