A Study of Modified Stem Cells in Stable Ischemic Stroke

December 19, 2016 updated by: SanBio, Inc.

A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke

The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and and with no further improvement from physical therapy.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Chronic, stable stroke patients have no existing alternative treatments after rehabilitation therapy. SB623, a modified stem cell preparation, has been shown to improve motor function when administered in animal models of stable stroke. Safety studies in animals have shown no adverse events attributed to SB623. Patients who meet the entry criteria for this study will have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two years. Regular neurological evaluations will also be done using standard questionnaires, with occasional video recording if improvements are evident. Key entry criteria for this study, in addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g., difficulty standing or walking, and/or difficulty using arms or hands, and/or speech impediments.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294-3410
        • University of Alabama
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented history of one completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement
  • Between 6 and 60 months post-stroke, and having a motor neurological deficit
  • No significant further improvement with physical therapy/rehabilitation
  • Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and positron-emission tomography (PET) scans of the head

Exclusion Criteria:

  • History of more than 1 symptomatic stroke
  • History of seizures
  • History or presence of any other major neurological disease
  • Myocardial infarction within prior 6 mos.
  • Known presence of any malignancy except squamous or basal cell carcinoma of the skin
  • Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
  • Contraindications to head CT, MRI, or PET
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB623
Administration of modified stem cells, SB623
SB623, a modified stem-cell product, will be administered at 3 dose levels. Each patient in one of three groups will be given a dose of 2.5, 5.0, or 10 million cells once. Each group will be completed before going to the next higher-dose group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Two years
Safety will be evaluated using the WHO safety criteria, by periodic MRIs, frequent laboratory monitoring, and by periodic measurements of possible humoral and cell-mediated immunological changes
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in stroke symptoms and brain metabolism
Time Frame: Two Years
Possible improvement in stroke symptoms will be determined by a variety of neurological assessments: European Stroke Scale, NIH Stroke Scale, Modified Rankin Score, and Fugl-Meyer assessment. Possible improvement in brain metabolism will be assessed using FDG-PET scans.
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gary K Steinberg, M.D., Ph.D., Stanford University
  • Principal Investigator: Lawrence R Wechsler, M.D., University of Pittsburgh Medical Center
  • Principal Investigator: Joshua M Rosenow, M.D.,FACS, Northwestern University Feinberg School of Medicine
  • Principal Investigator: James Markert, M.D., University of Alabama at Birmingham
  • Principal Investigator: Robert E Gross, M.D., Ph.D., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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