NCT01287936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

4.6 years

First QC Date

January 27, 2011

Results QC Date

June 2, 2022

Last Update Submit

January 31, 2023

Conditions

Chronic Ischemic Stroke

Keywords

Chronic StrokeStable StrokeIschemic StrokeFixed Motor Deficits

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

    Number of subjects with TEAEs by maximum severity. The severity of all AEs was assessed by the Investigator using the World Health Organization (WHO) Toxicity Scale. For abnormalities not found elsewhere in the WHO table, the following scale was used to assign severity: Mild: Transient mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: Mild-to-moderate limitation in activity; some assistance may be need. No or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required; hospitalization or prolongation of current hospitalization possible. Life-threatening: Extreme limitation in activity, significant assistance required; significant medial intervention/therapy required; hospitalization or prolongation of current hospitalization or hospice care probable.

    6 months

Secondary Outcomes (9)

  • Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6

    6 months

  • Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6

    6 months

  • Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6

    6 months

  • Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6

    6 months

  • Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6

    6 months

  • +4 more secondary outcomes

Study Arms (3)

SB623 Implant (2.5M)

EXPERIMENTAL

2.5 million SB623 cells

Biological: SB623

SB623 Implant (5.0M)

EXPERIMENTAL

5 million SB623 cells

Biological: SB623

SB623 Implant (10.0M)

EXPERIMENTAL

10 million SB623 cells

Biological: SB623

Interventions

SB623BIOLOGICAL

SB623, a modified stem-cell product

SB623 Implant (10.0M)SB623 Implant (2.5M)SB623 Implant (5.0M)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama

Birmingham, Alabama, 35294-3410, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 30497166DERIVED

  • 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.

    PMID: 27256670DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Bijan Nejadnik M.D.; Chief Medical Officer
Organization
SanBio, Inc.
Bijan.Nejadnik@sanbio.com
650-625-2205

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 3, 2023

Results First Posted

February 3, 2023

Record last verified: 2023-01

Locations

US(5)