Spinocerebellar Ataxia - All Sub-typesPhase 1/2NEURO-SCPNCT07467733
Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy
A Phase 1/2 study testing Intrathecal infusion and Intranasal infusion in people with Spinocerebellar Ataxia - All Sub-types, run by Biocells Medical at 1 site in Poland.
Trial summary
This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spinocerebellar Ataxia - All Sub-types
- What is being tested?
- Intrathecal infusion and Intranasal infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Phase 1/2
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.
Who cannot join
- Severe systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.
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, 02-797
Anita Gerder, +48223074882, info@biocellsmedical.com
About this study
Official title: Phase I/II Randomized Controlled Study Evaluating the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy
This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.
- Conditions
- Spinocerebellar Ataxia - All Sub-types
- Being tested
- Intrathecal infusion, Intranasal infusion
- Keywords
- ataxia, mesenchymal stem cells, exosomes
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal infusionDrug
200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
Intranasal infusionDrug
Intranasal infusion of purified exosomes derived from mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Neuroinduced Mesenchymal Stem Cells | Experimental | Not described Receives: Drug: Intrathecal infusion |
| Mesenchymal Stem Cell Derived Exosomes | Experimental | Not described Receives: Drug: Intranasal infusion |
| Saline solution | Placebo comparator | Not described Receives: Drug: Intranasal infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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; 0 - the best motor impairment
Measured: 92 weeks
SARA
Change in motor function as measured by the Scale for the Assessment and Rating of Ataxia (SARA) Range: 0-40 40 - the most severe ataxia; 0 - the mildest
Measured: 92 weeks
Secondary outcomes (1)
ICARS
Change in neurological function measured by the International Cooperative Ataxia Rating Scale (ICARS) Range: 0-100 100 is the worst neurological impairment; 0 - the best
Measured: 92 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia - All Sub-typesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT07467733
- Sponsor's protocol ID
- Bio120006
- Acronym
- NEURO-SCP
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No