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Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090932
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : December 20, 2019
University of South Florida
Information provided by (Responsible Party):
Benjamin Murdock, University of Michigan

Brief Summary:
Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized by progressive muscle weakness and eventual death. Studies demonstrate that the immune system plays a key role in ALS progression; however, the role of the immune system is unclear, as various aspects can play both a beneficial and detrimental role in the disease course. Attempts to universally suppress the immune system in ALS patients have at best had negligible effects on progression or at worst accelerated the disease. Thus, there is a critical need to identify immune cell populations to serve as biomarkers and therapeutic targets.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Blood draw

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
Actual Study Start Date : January 18, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021

Intervention Details:
  • Other: Blood draw
    Research subjects will have two tubes of blood drawn, approximately 20mL.

Primary Outcome Measures :
  1. Total number of classical NK (natural killer) cells; total number of CD3+ CD4+ CD8+ cells [ Time Frame: Every 28 days (+/- 5 days) for 12 months ]
    Total number of classical NK cells; total number of CD3+ CD4+ CD8+ cells

Secondary Outcome Measures :
  1. Cytokine expression [ Time Frame: Every 28 days (+/- 5 days) for 12 months ]
    Cytokine expression levels of these cell populations using qPCR, RNA-Seq, or Luminex.

Biospecimen Retention:   Samples With DNA
Innate lymphoid cells from whole blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ALS patients (60) and matched controls (5)

Inclusion Criteria:

  • Age 18 years or older.
  • Clinically definite, probable, probable laboratory supported, or possible ALS by El Escorial criteria
  • Fluency in English at the 6th grade level or higher.
  • Able to communicate sufficiently well by speaking
  • Able to communicate over the phone.
  • Capable of providing informed consent.
  • Lives geographically accessible to the University of Michigan

Exclusion Criteria:

  • Unable to provide informed consent.
  • Clinically significant dementia, as judged by the site investigator.
  • Other neurological or psychiatric disorders which are expected to impair cognitive function.
  • Other serious and uncontrolled medical disorders.
  • History of autoimmune disease.
  • Use of prednisone, IVIG, or immunosuppression within the last 12 months.
  • Not geographically accessible to the University of Michigan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03090932

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Contact: Blake Swihart, MA 734-936-8775

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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ben Murdock, PhD         
Principal Investigator: Ben Murdock, PhD         
Sponsors and Collaborators
University of Michigan
University of South Florida
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Principal Investigator: Ben Murdock, PhD University of Michigan
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Responsible Party: Benjamin Murdock, Research Investigator, University of Michigan Identifier: NCT03090932    
Other Study ID Numbers: HUM00107546
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases