SPMS Cohort for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Utah Health Imaging and Neurosciences Center, Salt Lake City, UT
Multiple Sclerosis+4 More
Ferumoxytol infusion - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.

Eligible Conditions

  • Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis (SPMS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 96 hours ±24 hours

96 hours ±24 hours
Incidence of treatment-emergent adverse events (safety and tolerability)
Safety and tolerability of ferumoxytol
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

SPMS Cohort
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: SPMS Cohort · No Placebo Group · Phase < 1

SPMS CohortExperimental Group · 3 Interventions: Ferumoxytol infusion, Gadoteridol, MRI Brain and Cervical Spine · Intervention Types: Drug, Drug, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol infusion
2021
Completed Early Phase 1
~10
Gadoteridol
2015
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 96 hours ±24 hours

Trial Background

Prof. M. Mateo Paz Soldan, Assistant Professor, Department of Neurology, Division of Neuroimmunology
Principal Investigator
University of Utah
Closest Location: University of Utah Health Imaging and Neurosciences Center · Salt Lake City, UT
Photo of Salt Lake City  1Photo of Salt Lake City  2Photo of Salt Lake City  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Multiple Sclerosis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have clinically diagnosed with secondary progressive multiple sclerosis (SPMS).
You are able to walk at least 20 meters without rest, with or without aid.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.