Clinical Trials Logo
  1. Home
  2. Amyotrophic Lateral Sclerosis
  3. NCT02058732
  4. Details
NCT02058732 Clinical Trial

Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02058732
Other study ID # HUM00078370
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date September 30, 2015

Study information
Verified date June 2018
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant. Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date September 30, 2015
Est. primary completion date September 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. 18 years of age or older

2. Subjects with amyotrophic lateral sclerosis -

Exclusion Criteria:

1. Do not have opportunistic central nervous system infection

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 -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
United States University of Michigan Hospital Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Terminated NCT04428775 - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease Phase 2
Recruiting NCT04998305 - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps Phase 1/Phase 2
Recruiting NCT05951556 - Telehealth Implementation of Brain-Computer Interface N/A
Terminated NCT04579666 - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT04082832 - CuATSM Compared With Placebo for Treatment of ALS/MND Phase 2/Phase 3
Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed NCT02496767 - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year Phase 3
Recruiting NCT04816227 - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting NCT04494256 - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation Phase 1/Phase 2
Completed NCT03706391 - Study of ALS Reversals 4: LifeTime Exposures
Recruiting NCT04882904 - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. N/A
Completed NCT04557410 - Open Label Study: Treatment of ALS Fatigue With PolyMVA Phase 1
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT04220190 - RAPA-501 Therapy for ALS Phase 2/Phase 3
Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A