MSA - Multiple System AtrophyPhase 2NCT07465198
Autologous Stem Cell Therapy in Patients With Multiple System Atrophy
A Phase 2 study testing MSCs in people with MSA - Multiple System Atrophy and MSA, run by Biocells Medical at 1 site in Poland.
Trial summary
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- MSA - Multiple System Atrophy, MSA
- What is being tested?
- MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2026to 1 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple System Atrophy (MSA-P or MSA-C)
- Age range of 35 to 65 years
Who cannot join
- Other major neurological disorders
- Severe cardiac/renal/hepatic impairment
- Prior stem cell therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
BioCells Medical
Warsaw
Miron Danielevich, PhD, +48660639936, info@biocellsmedical.com
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Autologous Stem Cell Therapy in Patients With Multiple System Atrophy
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.
- Conditions
- MSA - Multiple System Atrophy, MSA
- Being tested
- MSCs, Placebo
- Keywords
- MSA, Multiple System Atrophy, MSC, Mesenchimal stem cells
- Medical subject headings
- Shy-Drager Syndrome, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCsDrug
IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period
PlaceboOther
Intravenous 0.9% saline infusion, volume- and appearance-matched
| Study group | Role | What they receive |
|---|---|---|
| MSC therapy | Experimental | 200,000,000 cells per infusion Receives: Drug: MSCs |
| Saline Solution | Placebo comparator | 0.9% saline infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Measured: At week 48 from baseline
Secondary outcomes (1)
Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36)
Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36) Total Score with Range: 0-100 where 0 is the lowest value and 100 is the highest; higher scores indicate better health-related quality of life at Week 48
Measured: At week 48 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSA - Multiple System AtrophyStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocells Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465198
- Sponsor's protocol ID
- Bio120004
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Autologous Stem Cell Therapy in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07465198
- Acronym / sponsor ID
- Bio120004
- Conditions
- MSA - Multiple System Atrophy, MSA
- Keywords
- MSA, Multiple System Atrophy, MSC, Mesenchimal stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biocells MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 11 Mar 2026 (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.
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC therapy | Experimental | Drug: MSCs200,000,000 cells per infusion |
| Saline Solution | Placebo comparator | Other: Placebo0.9% saline infusion |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Multiple System Atrophy (MSA-P or MSA-C)
- Age range of 35 to 65 years
Key exclusion criteria (3 listed)
- Other major neurological disorders
- Severe cardiac/renal/hepatic impairment
- Prior stem cell therapy
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 |
|---|---|---|
| MSCsIV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period | Drug | MSC therapy |
| PlaceboIntravenous 0.9% saline infusion, volume- and appearance-matched | Other | Saline Solution |
Primary outcome
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: At week 48 from baseline
1 secondary outcome
Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36)
Time frame: At week 48 from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSCs in people with MSA - Multiple System Atrophy and MSA, 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 2 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: opening soon, as of the sponsor's last update on 11 Mar 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrei Peskau, M.D. (+48660639936, info@biocellsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unified Multiple System Atrophy Rating Scale (UMSARS) (time frame: At week 48 from baseline). 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 11 Mar 2026.