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

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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07467733

Acronym

NEURO-SCP

Enrollment

Registered

2026-03-12

Start date

2026-06-01

Completion date

2029-06-01

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxia - All Sub-types

Keywords

ataxia, mesenchymal stem cells, exosomes

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
MDS-UPDRS	92 weeks	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
SARA	92 weeks	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

Secondary

Measure	Time frame	Description
ICARS	92 weeks	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

Countries

Poland

Contacts

CONTACTAndrei Peskau

info@biocellsmedical.com+48452365311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026