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

Multiple Sclerosis

From 18 to 65 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Early Phase 1
Interventional
Study Start: July 2020

See protocol details

Summary

Principal SponsorBiocells Medical
Last updated: August 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2020Actual 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 
Principal SponsorBiocells Medical
Last updated: August 28, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Multiple Sclerosis
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

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

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

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

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 MedicalWarsaw, PolandSee the location
SuspendedOne Study Center