A Study of Modified Stem Cells in Stable Ischemic Stroke

SanBio

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Ischemic Stroke

Treatments: Biological: SB623

Study type: Interventional

Funder types: Industry

Identifiers

NCT01287936

SB-STR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

SB623 Implant (2.5M)

Experimental group

Description:

2.5 million SB623 cells

Treatment:

Biological: SB623

SB623 Implant (5.0M)

Experimental group

Description:

5 million SB623 cells

Treatment:

Biological: SB623

SB623 Implant (10.0M)

Experimental group

Description:

10 million SB623 cells

Treatment:

Biological: SB623