Clinical trial NCT01287936: A Study of Modified Stem Cells in Stable Ischemic Stroke
Official title: A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Ischemic Stroke
Keywords: Chronic Stroke
Stable Stroke
Ischemic Stroke
Fixed Motor Deficits
Lead sponsor: SanBio, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 6 months
Secondary outcomes:
measure: Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6
timeFrame: 6 months
measure: Change in the Fugl-Meyer Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the Fugl-Meyer Motor Total Score (FMMS) Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the Fugl-Meyer Upper Extremity Motor Function Total Score From Baseline at Month 6
timeFrame: 6 months
measure: Change in the Fugl-Meyer Lower Extremity Motor Function Total Score From Baseline at Month 6
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Gary K Steinberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Lawrence R Wechsler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Joshua M Rosenow, M.D.,FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: James Markert, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Robert E Gross, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.