Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
調査の概要
詳細な説明
Application - HUM00107546
Study Title:
Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
Full Study Title:
Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS
If there are other U-M studies related to this project, enter the eResearch ID number (HUM#) or IRBMED Legacy study number. Examples of related projects include, but are not limited to:
00028826 - Epidemological Risk Factors and The Genetics of ALS
Principal Investigator:
- Benjamin Murdock, PhD
Study Team Members:
- Eva Feldman, MD, PhD Co-Investigator
- Stephen Goutman, MD Co-Investigator
- Claudia Figueroa-Romero, Research Investigator
- Crystal Pacut, Biorepository Coordinator
- Jayna Duell, Study Coordinator
- Blake Swihart, Study Coordinator
- Adam Patterson, Biostatistician
Project 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. Alternatively, augmenting or depleting specific immune cell populations in ALS mouse models alters the disease course and slows progression. Thus, there is a critical need to identify immune cell populations to serve as biomarkers and therapeutic targets.
Neuroinflammation is a hallmark of ALS in both human patients and mouse models. While clinical symptoms result from motor neuron degeneration, it is becoming increasingly clear that the immune system plays a key role in pathology. A variety of insults give rise to identical immune responses which go on to produce the characteristic clinical and histopathological manifestations of motor neuron disease. This makes the immune system an attractive target for therapeutics, as the wide variety of potential ALS sources all funnel through a common immunological pathway over the course of disease. The investigators recent studies have demonstrated that ALS patients have increased levels of several subpopulations of innate lymphoid cells (ILCs) in their peripheral blood. A subset of patients has ILC levels 5-10 times greater than those found in healthy control patients. The differences seen in the ILC levels in peripheral blood are much greater differences seen in other immune cell populations during ALS. Thus, these cell populations are attractive candidates for use as biomarkers or therapeutic targets.
The proposed study can be broken into three broad phases which will applicable to each patient: recruitment, sample collection, and analysis. Following diagnosis of disease, ALS patients who live within 1 hour of the University of Michigan will be called by our clinical coordinator and enrolled in the study (recruitment). Following enrollment in the study, each of the patients will be visited once every 28 ± 5 days for a year after the initial visit by a Michigan Institute for Clinical & Health Research (MICHR) clinical research unit; this unit will take 20 ml of blood per patient. Samples will then be returned to the University of Michigan. ILCs will be isolated from peripheral blood using fluorescence-activated cell sorting (FACS) and the mRNA of each ILC population will be collected and cytokine production analyzed using multiplex (analysis). On the day of collection, a clinician or clinical coordinator from the University of Michigan Comprehensive ALS Clinic (UMCAC) will contact the patient to complete an ALSFRS-R questionnaire to assess the physical deterioration of the patients.
The study will also incorporate control subjects. The control subjects will have blood taken once a month for 12 total visits over 36 months, but will not complete the ALSFRS-R questionnaire as they will not have been diagnosed with ALS and therefore the questionnaire does not fit; 20ml of blood will be taken per visit.
Subjects need to live within approximately 60 miles of the University of Michigan.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Total number of classical NK (natural killer) cells; total number of CD3+ CD4+ CD8+ cells
時間枠:Every 28 days (+/- 5 days) for 12 total visits over 36 months
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Total number of classical NK cells; total number of CD3+ CD4+ CD8+ cells
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Every 28 days (+/- 5 days) for 12 total visits over 36 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Cytokine expression
時間枠:Every 28 days (+/- 5 days) for 12 total visits over 36 months
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Cytokine expression levels of these cell populations using qPCR, RNA-Seq, or Luminex.
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Every 28 days (+/- 5 days) for 12 total visits over 36 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ben Murdock, PhD、University of Michigan
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HUM00107546
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Blood drawの臨床試験
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