NCT07146087

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

Suspended EARLY_PHASE1 Last updated 28 August 2025

What this trial tests

EARLY_PHASE1 trial testing MSC-Derived Exosomes in Multiple Sclerosis in 20 participants. Suspended.

Timeline

1 July 2020

Primary endpoint
30 June 2023

31 December 2027

Quick facts

Lead sponsor	Biocells Medical
Phase	EARLY_PHASE1
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	other
Enrollment	20
Start date	1 July 2020
Primary completion	30 June 2023
Estimated completion	31 December 2027
Sites	1 location across Poland

Drugs / interventions tested

• MSC-Derived Exosomes — full drug profile →
• Placebo (Normal Saline)

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Biocells Medical — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Uncovering the Secret of Mesenchymal Stromal Cells Secretome: From Extracellular Vesicle Cargo to Neuroprotection.
   Joseph M, Gabrielli M, Tonoli E, Cave GWV, et al · · 2026 · PMID 42193898 · DOI 10.3390/cells15100889
2. Exosome-loaded hydrogels for bone regeneration: a cell-free therapeutic strategy.
   Jin S, Zhou S. · · 2026 · PMID 41857754 · DOI 10.1186/s13036-026-00659-4
3. Extracellular Vesicles in Autoimmune Diseases: From Diagnostic Biomarkers to Engineered Therapeutics.
   Wu Y, Ma H, Zhu T, Huang S, et al · · 2026 · PMID 41677384 · DOI 10.1002/advs.202521802
4. Research progress and application prospect of engineered small extracellular vesicles.
   Zhang H, Chen J, Tang X, Liu X, et al · · 2026 · PMID 41562261 · DOI 10.1177/09636897251409473
5. Research progress on pyroptosis regulated by mesenchymal stem cell-derived exosomes.
   Yang T, An J, Xu X, Li B, et al · · 2025 · PMID 41425572 · DOI 10.3389/fimmu.2025.1717465