A Study of Modified Stem Cells in Stable Ischemic Stroke

NCT ID: NCT01287936

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-08-31

Brief Summary

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 with no further improvement from physical therapy.

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.

Conditions

Chronic Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SB623 Implant (2.5M)

2.5 million SB623 cells

Group Type: EXPERIMENTAL

SB623

Intervention Type: BIOLOGICAL

SB623, a modified stem-cell product

SB623 Implant (5.0M)

5 million SB623 cells

Group Type: EXPERIMENTAL

SB623

Intervention Type: BIOLOGICAL

SB623, a modified stem-cell product

SB623 Implant (10.0M)

10 million SB623 cells

Group Type: EXPERIMENTAL

SB623

Intervention Type: BIOLOGICAL

SB623, a modified stem-cell product

Interventions

SB623

SB623, a modified stem-cell product

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SanBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary K Steinberg, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Lawrence R Wechsler, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Joshua M Rosenow, M.D.,FACS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

James Markert, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Robert E Gross, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

University of Alabama

Birmingham, Alabama, United States

Stanford University School of Medicine

Stanford, California, United States

Emory University

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Kim AS, Johnson JN, Bates D, Poggio G, Case C, McGrogan M, Yankee EW, Schwartz NE. Two-year safety and clinical outcomes in chronic ischemic stroke patients after implantation of modified bone marrow-derived mesenchymal stem cells (SB623): a phase 1/2a study. J Neurosurg. 2018 Nov 23;131(5):1462-1472. doi: 10.3171/2018.5.JNS173147. Print 2019 Nov 1.

Reference Type: DERIVED

PMID: 30497166 (View on PubMed)

Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Coburn ML, Billigen JB, Kim AS, Johnson JN, Bates D, King B, Case C, McGrogan M, Yankee EW, Schwartz NE. Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study. Stroke. 2016 Jul;47(7):1817-24. doi: 10.1161/STROKEAHA.116.012995. Epub 2016 Jun 2.

Reference Type: DERIVED

PMID: 27256670 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SB-STR01

Identifier Type: -

Identifier Source: org_study_id