Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
NCT ID: NCT07146087
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
EARLY_PHASE1
20 participants
INTERVENTIONAL
2020-07-01
2027-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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MSC-Derived Exosomes
Participants receive intravenous infusions of allogeneic mesenchymal stem cell (MSC)-derived exosomes every 12 weeks for 48 weeks (total of 4 infusions) in addition to their stable background MS therapy (if any).
MSC-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).
Normal Saline
Participants receive intravenous infusions of 0.9% sodium chloride (saline) matched in volume, appearance, and schedule to the experimental arm, in addition to their stable background MS therapy (if any).
Placebo (Normal Saline)
0.9% sodium chloride solution matched to the experimental product in volume, appearance, infusion set-up, and administration procedures.
Interventions
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MSC-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).
Placebo (Normal Saline)
0.9% sodium chloride solution matched to the experimental product in volume, appearance, infusion set-up, and administration procedures.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed
3. EDSS score 3.0-6.5.
Exclusion Criteria
2. Other significant neurological or autoimmune disorders.
3. Active infection, malignancy, or uncontrolled systemic disease.
18 Years
65 Years
ALL
No
Sponsors
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Biocells Medical
INDUSTRY
Responsible Party
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Andrei Peskau
Specialist in regenerative medicine
Locations
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Biocells Medical
Warsaw, , Poland
Countries
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Other Identifiers
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Bio120002
Identifier Type: -
Identifier Source: org_study_id
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