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Not yet recruitingNCT07467733NEURO-SCPUpdated Mar 12, 2026

Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy

A Phase 1/2 interventional study of Intrathecal infusion and Intranasal infusion in Spinocerebellar Ataxia - All Sub-types, sponsored by Biocells Medical. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Biocells Medical · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.

02

Conditions studied

  • Spinocerebellar Ataxia - All Sub-types

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Keywords

  • ataxia
  • mesenchymal stem cells
  • exosomes
03

In context

Ataxia

149 studies on the registry are indexed under Ataxia; 37 are open to participants now.

This study's planned enrollment of 90 is above the median of 30 across 100 interventional studies indexed under Ataxia.

Browse Ataxia studies →

Lead sponsor

Biocells Medical is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide .

Exclusion criteria

Exclusion Criteria:

Severe systemic illness; Active infection; History of within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Neuroinduced Mesenchymal Stem Cells

    Drug: Intrathecal infusion

  • Experimental
    Mesenchymal Stem Cell Derived Exosomes

    Drug: Intranasal infusion

  • Placebo comparator
    Saline solution

    Drug: Intranasal infusion

Interventions

  • DrugIntrathecal infusion

    200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.

  • DrugIntranasal infusion

    Intranasal infusion of purified exosomes derived from mesenchymal stem cells

06

What researchers measure

Primary 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; 0 - the best motor impairment

    Time frame: 92 weeks

  2. 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

    Time frame: 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

    Time frame: 92 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07467733
Lead sponsor
Biocells Medical
Responsible party
Andrei Peskau (Biocells Medical, Biocells Medical) — Principal investigator
First posted
Mar 12, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Mar 12, 2026

Study contacts

Andrei Peskau
Contact
info@biocellsmedical.com
+48452365311

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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