Multiple Sclerosis
Conditions
Keywords
sclerosis, multiple sclerosis, MSC
Brief summary
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
Interventions
BIOLOGICALMSC-Derived Exosomes
Purified, sterile, acellular extracellular vesicles (exosomes) isolated from culture supernatant of GLP-manufactured allogeneic human bone-marrow-derived MSCs. Release criteria include particle size distribution 30-150 nm (nanoparticle tracking analysis), particle count, sterility/endotoxin testing, mycoplasma negative, and predefined protein/marker profile (e.g., CD9/CD63/CD81 positive).
BIOLOGICALPlacebo (Normal Saline)
0.9% sodium chloride solution matched to the experimental product in volume, appearance, infusion set-up, and administration procedures.
Sponsors
Biocells Medical
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Expanded Disability Status Scale (EDSS) score | 24 months from the day of administration | Unit of measure: points (range: 0-10; higher scores indicate worse disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in T2 lesion load and brain atrophy | 24 months after the first administration | On MRI Unit: number and volume of lesions (mm³). |
| Change in neurocognitive performance | 24 months after first administration | Assessed via Symbol Digit Modalities Test (SDMT). Unit: score (range: 0-110; higher scores mean better cognition). |
Countries
Poland
Outcome results
None listed