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Not yet recruiting NCT07467733

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

Phase I / Phase II Interventional Spinocerebellar Ataxia - All Sub-types

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrathecal infusion, Intranasal infusion.
Who it may be relevant to
Registry conditions: Spinocerebellar Ataxia - All Sub-types. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug Intrathecal infusion
    200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.
  • Drug Intranasal infusion
    Intranasal infusion of purified exosomes derived from mesenchymal stem cells

Primary outcome measures

  • MDS-UPDRS [Time frame: 92 weeks]
  • SARA [Time frame: 92 weeks]
Secondary outcome measures (1)
  • ICARS [Time frame: 92 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • BioCells Medical — Warsaw

Identifiers

NCT: NCT07467733 · Bio120006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗