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Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis

NCT07146087 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-28

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

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).

BIOLOGICAL

Placebo (Normal Saline)

0.9% sodium chloride solution matched to the experimental product in volume, appearance, infusion set-up, and administration procedures.

Sponsors & Collaborators

  • Biocells Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-06-30
Completion
2027-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146087 on ClinicalTrials.gov