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NCT Number: NCT07471230

Evaluation of Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism

This clinical trial investigates the safety and therapeutic potential of mesenchymal stem cell-based therapies in patients with parkinsonism.

The study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell-derived exosomes as potential regenerative treatments targeting neurodegeneration within dopaminergic pathways.

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Key information

Conditions

Parkinsonism or Parkinson's Disease Nos Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Parkinsonism in Diseases Classified Elsewhere Synucleinopathies

Age range

48 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 40-80 years Clinical diagnosis of Parkinsonism Hoehn and Yahr stage II-III Stable pharmacological treatment for ≥3 months

Exclusion criteria

Atypical parkinsonian syndromes unrelated to neurodegeneration History of malignancy within 5 years Severe cardiovascular disease Prior cellular therapy Active infection or immunosuppression

Treatment and study plan

Intrathecal (IT)

Biological

Intrathecal injection of 3 ml between L4-L5

Intravenous

Biological

Intravenous injection via a drip

Primary outcomes

  1. NMSS

    Time frame: 48

    Change in non-motor symptoms measured by the Non-Motor Symptoms Scale (NMSS) Range: 0-360 360 indicates the greatest symptom burden, 0 - the least

Secondary outcomes

  1. MDS-UPDRS

    Time frame: 48

    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 and 0 is 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 II Randomized Controlled Trial Evaluating Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism

Acronym: STEM-PARK

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2026
Registry last updated
Mar 13, 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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