Gold Nanocrystals for Multiple Sclerosis
(REPAIR-MS Trial)
Trial Summary
What is the purpose of this trial?
REPAIR-MS is a single-center open label, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with Multiple Sclerosis (MS) within fifteen (15) years of Screening. The primary endpoint for this study changes from baseline to week 12 in CNS metabolic changes, based on 31P-MRSimaging.
Will I have to stop taking my current medications?
Participants in Cohort 1 must continue their stable treatment with natalizumab, and those in Cohort 2 must continue their B-cell depleting therapy or S1P modulator therapy. The trial does not specify stopping other medications, but participants cannot be on other MS therapies or investigational drugs.
What data supports the effectiveness of the treatment CNM-Au8 for multiple sclerosis?
Research shows that gold nanocrystals can help repair damaged nerve coverings in animal models of multiple sclerosis, improving motor functions and promoting nerve cell growth. Additionally, gold nanoparticles have been found to reduce inflammation and slow disease progression in similar conditions.12345
Is CNM-Au8 safe for humans?
How is the drug CNM-Au8 different from other treatments for multiple sclerosis?
CNM-Au8 is unique because it uses gold nanocrystals to improve energy metabolism in brain cells, which helps protect nerves and repair damaged myelin (the protective covering of nerve fibers). Unlike other treatments, it is taken orally and works by enhancing the brain's energy processes, potentially offering a novel approach to treating multiple sclerosis.12567
Research Team
Peter Sguigna, MD
Principal Investigator
University of Texas Southwestern Medical Center
Eligibility Criteria
Adults aged 18-70 with Multiple Sclerosis (MS) diagnosed within the last 15 years. Participants must have stable MS or be on specific therapies for at least 48 weeks. They should not have had recent relapses, metal implants affected by MRI, significant medical conditions, drug abuse history, pregnancy plans during and post-trial without contraception use, or a gold allergy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily oral treatment with CNM-Au8 for CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation
Treatment Details
Interventions
- CNM-Au8
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clene Nanomedicine
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborator