Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressi
Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
What it found
No result yet.
Reason given: Slow enrolment of participants
What was tested
Treatment tested
- MSC-Derived Exosomes
Placebo
- Placebo (Normal Saline)
What it measured
Main measures
Change in Expanded Disability Status Scale (EDSS) score
24 months from the day of administration
Disability progression
Other measures (2)
Change in T2 lesion load and brain atrophy
24 months after the first administration
MRI lesionsBrain volume lossChange in neurocognitive performance
24 months after first administration
Thinking and memory
Who could take part
Progressive MS · 18 to 65 · EDSS 3.0 to 6.5
Show the full criteria
Inclusion criteria
1. Age 18-65 years. 2. Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed 3. EDSS score 3.0-6.5.
Exclusion criteria
1. Relapse or corticosteroid treatment within 3 months before screening. 2. Other significant neurological or autoimmune disorders. 3. Active infection, malignancy, or uncontrolled systemic disease.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The goal of this clinical trial is to learn if intravenous infusion of allogeneic mesenchymal stem cell (MSC)-derived exosomes can slow disability progression and improve neurological function in adults with progressive multiple sclerosis (MS). The trial will also evaluate the safety and tolerability of repeated exosome infusions. The main questions it aims to answer are: Does MSC-derived exosome therapy reduce disability progression as measured by the Expanded Disability Status Scale (EDSS)? Does MSC-derived exosome therapy decrease neuroinflammation and brain lesion burden compared with placebo? Researchers will compare participants who receive MSC-derived exosome therapy to those who receive placebo (saline infusion) to see if the treatment improves clinical and biological outcomes. Participants will: Receive either MSC-derived exosome infusions or placebo infusions every 3 months for 1 year (4 total infusions) Undergo clinical assessments (neurological exams, EDSS scoring, neurocognitive testing) Provide blood and cerebrospinal fluid samples for biomarker analysis Have MRI scans to evaluate lesion load and brain volume Complete questionnaires on quality of life and daily functioning
Papers
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History
Started
Jul 2020
Main results due
Jun 2023
Finished
Dec 2027