Parkinsonism or Parkinson's Disease NosPhase 2STEM-PARKNCT07471230
Evaluation of Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism
A Phase 2 study testing Intrathecal (IT) and Intravenous in people with Parkinsonism or Parkinson's Disease Nos and Parkinsonism in Diseases Classified Elsewhere, run by Biocells Medical at 1 site in Poland.
Trial summary
This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism. The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within… Read more about this study
- Who is it for?
- Ages 48 to 70 years
- Conditions the study is for
- Parkinsonism or Parkinson's Disease Nos, Parkinsonism in Diseases Classified Elsewhere
- What is being tested?
- Intrathecal (IT) and Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 23 Nov 2026to 23 Nov 2029
- 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 48 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months
Who cannot join
- Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression
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
Neuropostep
Warsaw, 02-797
Anita Gerder, +48223074882, info@biocellsmedical.com
About this study
Official title: Phase II Randomized Controlled Trial Evaluating Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism
This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.
The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.
- Being tested
- Intrathecal (IT), Intravenous
- Keywords
- mesenchymal, exosomes, parkinsonism, stem cells
- Medical subject headings
- Parkinsonian Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal (IT)Biological
Intrathecal injection of 3 ml between L4-L5
IntravenousBiological
Intravenous injection via a drip
| Study group | Role | What they receive |
|---|---|---|
| Neuroinduced Mesenchymal Stem Cells | Experimental | 200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion. Receives: Biological: Intrathecal (IT) |
| Mesenchymal Stem Cell Derived Exosomes | Experimental | 1×10¹¹ particles per infusion Receives: Biological: Intravenous |
| Intravenous saline infusion | Placebo comparator | Not described Receives: Biological: Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMSS
Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least
Measured: 48
Secondary outcomes (1)
MDS-UPDRS
Change in motor symptoms measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Motor Examination Range: 0-132 Where 132 is the worst motor impairment and 0 is the best
Measured: 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Nov 2026 (estimated)
- Primary completion23 Nov 2028 (estimated)
- Study completion23 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonism or Parkinson's Disease NosStudies 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
- 120 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
- NCT07471230
- Sponsor's protocol ID
- Bio120007
- Acronym
- STEM-PARK
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial Evaluating Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism
- ClinicalTrials.gov ID
- NCT07471230
- Acronym / sponsor ID
- STEM-PARK / Bio120007
- Keywords
- mesenchymal, exosomes, parkinsonism, stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Biocells MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 23 Nov 2028 (estimated)
- Study completion
- 23 Nov 2029 (estimated)
- First posted
- 13 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 clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.
The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuroinduced Mesenchymal Stem Cells | Experimental | Biological: Intrathecal (IT)200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion. |
| Mesenchymal Stem Cell Derived Exosomes | Experimental | Biological: Intravenous1×10¹¹ particles per infusion |
| Intravenous saline infusion | Placebo comparator | Biological: Intravenous |
Who may qualify
- Ages
- 48 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months
Key exclusion criteria (1 listed)
- Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression
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 |
|---|---|---|
| Intrathecal (IT)Intrathecal injection of 3 ml between L4-L5 | Biological | Neuroinduced Mesenchymal Stem Cells |
| IntravenousIntravenous injection via a drip | Biological | Intravenous saline infusion, Mesenchymal Stem Cell Derived Exosomes |
Primary outcome
NMSS
Time frame: 48
Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least
1 secondary outcome
MDS-UPDRS
Time frame: 48
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 13 Mar 2026.
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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 Intrathecal (IT) and Intravenous in people with Parkinsonism or Parkinson's Disease Nos and Parkinsonism in Diseases Classified Elsewhere, 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 1 inclusion and 1 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 13 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 (+48452365311, info@biocellsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMSS (time frame: 48). 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 13 Mar 2026.