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NCT Number: NCT07467733

Evaluation of 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal infusion

Drug

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

Intranasal infusion

Drug

Intranasal infusion of purified exosomes derived from mesenchymal stem cells

Primary outcomes

  1. MDS-UPDRS

    Time frame: 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

  2. SARA

    Time frame: 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 outcomes

  1. ICARS

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Peskau

CONTACT

[email protected]

+48452365311

Sponsors and collaborators

Lead sponsor

Biocells Medical

Industry

Registry information

Official study 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

Acronym: NEURO-SCP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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