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

Early Phase 1SuspendedNCT07146087

Biocells Medical20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

MSC-Derived ExosomesBIOLOGICAL

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)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Expanded Disability Status Scale (EDSS) score

Unit of measure: points (range: 0-10; higher scores indicate worse disability).

Time frame: 24 months from the day of administration

Secondary Outcomes

Change in T2 lesion load and brain atrophy

On MRI Unit: number and volume of lesions (mm³).

Time frame: 24 months after the first administration

Change in neurocognitive performance

Assessed via Symbol Digit Modalities Test (SDMT). Unit: score (range: 0-110; higher scores mean better cognition).

Time frame: 24 months after first administration