A Study of Modified Stem Cells in Stable Ischemic Stroke
This study is ongoing, but not recruiting participants.
Sponsor:
SanBio, Inc.
Information provided by (Responsible Party):
SanBio, Inc.
ClinicalTrials.gov Identifier:
NCT01287936
First received: January 27, 2011
Last updated: November 16, 2015
Last verified: November 2015
| Tracking Information | ||||||||||||||||
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| First Received Date ICMJE | January 27, 2011 | |||||||||||||||
| Last Updated Date | November 16, 2015 | |||||||||||||||
| Start Date ICMJE | January 2011 | |||||||||||||||
| Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | |||||||||||||||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: Two years ] [ Designated as safety issue: Yes ] Safety will be evaluated using the WHO safety criteria, by periodic MRIs, frequent laboratory monitoring, and by periodic measurements of possible humoral and cell-mediated immunological changes |
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| Original Primary Outcome Measures ICMJE |
Safety [ Time Frame: Two years ] [ Designated as safety issue: Yes ] Safety will be evaluated using the WHO safety criteria and by periodic MRIs |
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| Change History | Complete list of historical versions of study NCT01287936 on ClinicalTrials.gov Archive Site | |||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Improvement in stroke symptoms and brain metabolism [ Time Frame: Two Years ] [ Designated as safety issue: No ] Possible improvement in stroke symptoms will be determined by a variety of neurological assessments: European Stroke Scale, NIH Stroke Scale, Modified Rankin Score, and Fugl-Meyer assessment. Possible improvement in brain metabolism will be assessed using FDG-PET scans. |
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| Original Secondary Outcome Measures ICMJE |
Improvement in stroke symptoms and brain metabolism [ Time Frame: 6-24 months ] [ Designated as safety issue: No ] Possible improvement in stroke symptoms will be deterimed by a variety of neurological assessments: European Stroke Scale, NIH Stroke Scale, Modified Rankin Score, and Fugl-Meyer assessment. Possible improvement in brain metabolism will be assessed using FDG-PET scans. |
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| Current Other Outcome Measures ICMJE | Not Provided | |||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||||||||
| Descriptive Information | ||||||||||||||||
| Brief Title ICMJE | A Study of Modified Stem Cells in Stable Ischemic Stroke | |||||||||||||||
| Official Title ICMJE | A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke | |||||||||||||||
| 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 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. | |||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Ischemic Stroke | |||||||||||||||
| Intervention ICMJE | Biological: SB623
SB623, a modified stem-cell product, will be administered at 3 dose levels. Each patient in one of three groups will be given a dose of 2.5, 5.0, or 10 million cells once. Each group will be completed before going to the next higher-dose group. |
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| Study Arm (s) | Experimental: SB623
Administration of modified stem cells, SB623
Intervention: Biological: SB623 |
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| Publications * | Not Provided | |||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||||||||
| Estimated Enrollment ICMJE | 18 | |||||||||||||||
| Estimated Completion Date | June 2016 | |||||||||||||||
| Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||||||||||||||
| Ages | 18 Years to 75 Years (Adult, Senior) | |||||||||||||||
| Accepts Healthy Volunteers | No | |||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
| Listed Location Countries ICMJE | United States | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT01287936 | |||||||||||||||
| Other Study ID Numbers ICMJE | SB-STR01 | |||||||||||||||
| Has Data Monitoring Committee | Yes | |||||||||||||||
| Plan to Share Data | Not Provided | |||||||||||||||
| IPD Description | Not Provided | |||||||||||||||
| Responsible Party | SanBio, Inc. | |||||||||||||||
| Study Sponsor ICMJE | SanBio, Inc. | |||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||
| Investigators ICMJE |
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| Information Provided By | SanBio, Inc. | |||||||||||||||
| Verification Date | November 2015 | |||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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