Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

NCT02058732 | Terminated DMC

• 1 other identifier: HUM00078370
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.

  1\. The longitudinal changes in spinal cord metabolites in amyotrophic lateral sclerosis(ALS) stem cell treated patients will be compared to amyotrophic lateral sclerosis(ALS) non-treated patients using magnetic resonance spectroscopy. Investigators hypothesize that amyotrophic lateral sclerosis(ALS) stem cell treated patients will demonstrate attenuated rates of decline in the levels of N-acetylaspartate(NAA), a measure of neuronal integrity, in the cervical spinal cord than amyotrophic lateral sclerosis(ALS) non-treated patients.

  5 years

Study Arms (2)

ALS patients receivng stem cells

ACTIVE COMPARATOR

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.

Other: MRI

ALS patients not receiving stem cells

ACTIVE COMPARATOR

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.

Other: MRI

Interventions

MRI OTHER

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; ALS patients receivng stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Subjects with amyotrophic lateral sclerosis -

You may not qualify if:

• Do not have opportunistic central nervous system infection
• Do not have a history of head injury
• Do not have cerebrovascular disease
• Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
• Must not be pregnant -

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bradley Foerster, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: February 10, 2014
• Study Start: November 1, 2013
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)