Suspended

Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis

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What is being tested

MSC-Derived Exosomes

+ Placebo (Normal Saline)

Biological
Who is being recruted

Autoimmune Diseases+7

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorBiocells Medical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2020

Actual date on which the first participant was enrolled.

This clinical trial aims to determine if a new treatment using special particles called exosomes, derived from mesenchymal stem cells (MSC), can help people with progressive multiple sclerosis (MS). The study focuses on whether these exosomes can slow down the worsening of disabilities and enhance nerve function. It will also assess how safe and tolerable these exosome infusions are for participants. The trial targets adults living with progressive MS, a condition where symptoms gradually get worse, and aims to find ways to improve their quality of life and manage symptoms more effectively. Participants in the study will receive either the exosome treatment or a placebo, which is a harmless saline solution, through an intravenous infusion every three months for one year. The study will involve a series of assessments to track any changes in their condition. These include neurological exams, scoring of disability levels, and cognitive tests. Blood and spinal fluid samples will be collected to look for biological indicators of treatment effect. MRI scans will be used to check for changes in brain lesions and volume. Additionally, participants will fill out questionnaires about their quality of life and daily activities, providing a comprehensive view of how the treatment impacts their lives.

Official TitleAllogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
NCT07146087
Principal SponsorBiocells Medical
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesPathologic ProcessesSclerosisPathological Conditions, Signs and SymptomsAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

Criteria

3 inclusion criteria required to participate
Age 18-65 years.

Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed

EDSS score 3.0-6.5.

3 exclusion criteria prevent from participating
Relapse or corticosteroid treatment within 3 months before screening.

Other significant neurological or autoimmune disorders.

Active infection, malignancy, or uncontrolled systemic disease.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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).

Group II

Placebo
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Biocells Medical

Warsaw, PolandOpen Biocells Medical in Google Maps
SuspendedOne Study Center