Phase 2
N=18
A Study of Modified Stem Cells in Stable Ischemic Stroke
Chronic Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01287936 ↗Enrolled (actual)
18
Serious AEs
38.9%
Results posted
Feb 2023
Primary outcome: Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) — 1; 1; 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB623 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SanBio, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs) |
1; 1; 0; 3; 2; 4 | — |
| SECONDARY Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6 |
7.67; 4.50; 7.75 | <0.001 sig |
| SECONDARY Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6 |
6.33; 3.67; 6.25 | — |
| SECONDARY Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6 |
-2.00; -0.83; -2.50 | 0.004 sig |
| SECONDARY Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6 |
-1.33; -0.83; -1.00 | — |
| SECONDARY Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6 |
0; -0.17; -0.25 | — |
| SECONDARY Change in the Fugl-Meyer Total Score From Baseline at Month 6 |
18.33; 17.70; 23.75 | — |
| SECONDARY Change in the Fugl-Meyer Motor Total Score (FMMS) Total Score From Baseline at Month 6 |
8.17; 8.67; 17.50 | — |
| SECONDARY Change in the Fugl-Meyer Upper Extremity Motor Function Total Score From Baseline at Month 6 |
4.00; 4.50; 11.25 | — |
| SECONDARY Change in the Fugl-Meyer Lower Extremity Motor Function Total Score From Baseline at Month 6 |
4.17; 4.17; 6.25 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01287936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.