Multiple SclerosisEarly Phase 1NCT07146087
Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
A Early Phase 1 study testing MSC-Derived Exosomes in people with Multiple Sclerosis, run by Biocells Medical at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSC-Derived Exosomes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed
- EDSS score 3.0-6.5.
Who cannot join
- Relapse or corticosteroid treatment within 3 months before screening.
- Other significant neurological or autoimmune disorders.
- Active infection, malignancy, or uncontrolled systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Multiple Sclerosis
- Being tested
- MSC-Derived Exosomes, Placebo (Normal Saline)
- Keywords
- sclerosis, multiple sclerosis, MSC
- Medical subject headings
- Multiple Sclerosis, Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MSC-Derived Exosomes | 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). Receives: Biological: MSC-Derived Exosomes |
| Normal Saline | Placebo comparator | 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). Receives: Biological: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Disability Status Scale (EDSS) score
Unit of measure: points (range: 0-10; higher scores indicate worse disability).
Measured: 24 months from the day of administration
Secondary outcomes (2)
Change in T2 lesion load and brain atrophy
On MRI Unit: number and volume of lesions (mm³).
Measured: 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).
Measured: 24 months after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jul 2020
- Primary completion30 Jun 2023
- Study completion31 Dec 2027 (estimated)
Why it stopped: Slow enrolment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocells Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Andrei Peskau, Biocells Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146087
- Sponsor's protocol ID
- Bio120002
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07146087
- Acronym / sponsor ID
- Bio120002
- Conditions
- Multiple Sclerosis
- Keywords
- sclerosis, multiple sclerosis, MSC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Slow enrolment of participants
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Biocells MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC-Derived Exosomes | Experimental | Biological: MSC-Derived ExosomesParticipants 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). |
| Normal Saline | Placebo comparator | Biological: Placebo (Normal Saline)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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed
- EDSS score 3.0-6.5.
Key exclusion criteria (3 listed)
- Relapse or corticosteroid treatment within 3 months before screening.
- Other significant neurological or autoimmune disorders.
- Active infection, malignancy, or uncontrolled systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC-Derived ExosomesPurified, 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 | MSC-Derived Exosomes |
| Placebo (Normal Saline)0.9% sodium chloride solution matched to the experimental product in volume, appearance, infusion set-up, and administration procedures. | Biological | Normal Saline |
Primary outcome
Change in Expanded Disability Status Scale (EDSS) score
Time frame: 24 months from the day of administration
Unit of measure: points (range: 0-10; higher scores indicate worse disability).
2 secondary outcomes
Change in T2 lesion load and brain atrophy
Time frame: 24 months after the first administration
Change in neurocognitive performance
Time frame: 24 months after first administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MSC-Derived Exosomes in people with Multiple Sclerosis, run by Biocells Medical at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expanded Disability Status Scale (EDSS) score (time frame: 24 months from the day of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.