A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
Studieöversikt
Status
Detaljerad beskrivning
Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.
This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Utah
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Salt Lake City, Utah, Förenta staterna, 84103
- Rocky Mountain MS Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
45 participants will be enrolled into a study to examine the microRNA and cell products profile in both cerebrospinal fluid (CSF) and blood. Study population will consist of a total of: 20 CIS patients defined as patients having a single attack (or the appearance of one or more symptoms characteristic of MS) high risk of developing MS, when no other diseases or causes are apparent.
20 SPMS patients 5 normal, non-diseased controls
Beskrivning
Inclusion Criteria:
- able to understand and agree to informed consent;
- male or female patients 18-68 years of age
- no disease modifying therapy 60 days prior to Baseline
- EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
- Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
- weight 46 kilograms to 127 kilograms inclusive
- no active systemic infection
- not currently pregnant or breast feeding
- no history of corticosteroid treatment or relapse within 60 days prior to Baseline.
Exclusion Criteria:
- not able to understand informed consent
- if any of the inclusion criteria is not met
- HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
- positive pregnancy test
- patient withdraws consent
- Coumadin use within 60 days prior to Baseline
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
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Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
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Healthy participants
No immunological or neurological illnesses.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
Tidsram: baseline
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baseline
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Correlate microRNA profiles with clinical and CSF inflammation indexes
Tidsram: baseline
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baseline
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: John F Foley, MD, Rocky Mountain MS Research Group, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 003-001-GEN
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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