Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
NCT ID: NCT02058732
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2013-11-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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ALS patients receivng stem cells
Amyotrophic lateral sclerosis(ALS)subjects, who will be receiving stem cells, will undergo a brief clinical evaluation and questionnaire that will last approximately 20 to 30 min. Subjects will be asked to undergo magnetic resonance imaging(MRI)scans of the cervical spine and brain that will last approximately 60 minutes.
MRI
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
ALS patients not receiving stem cells
Amyotrophic lateral sclerosis(ALS)patient who will not be receiving stem cells, will have an MRI that lasts approximately 60 minutes. This MRI will be repeated at three different time points. Subjects will have an initial MRI, then another at both 6 and 12 months after the initial magnetic resonance imaging(MRI)scan. Subjects will also complete a clinical examination which will take approximately 30 minutes for each MRI. The follow-up magnetic resonance imaging(MRI)scans done for ALS patients who do not receive stem cells are part of routine clinical studies and therefore subjects will not be billed.
MRI
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
Interventions
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MRI
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
Eligibility Criteria
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Inclusion Criteria
2. Subjects with amyotrophic lateral sclerosis -
Exclusion Criteria
2. Do not have a history of head injury
3. Do not have cerebrovascular disease
4. Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
5. Must not be pregnant -
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Principal Investigators
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Bradley Foerster, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Hospital
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00078370
Identifier Type: -
Identifier Source: org_study_id
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