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Not yet recruiting NCT07471230

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

Phase II Interventional Parkinsonism or Parkinson's Disease Nos Parkinsonism in Diseases Classified Elsewhere

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 (IT), Intravenous.
Who it may be relevant to
Registry conditions: Parkinsonism or Parkinson's Disease Nos, Parkinsonism in Diseases Classified Elsewhere. Basic parameters: 48 years — 70 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 →

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Official title

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

Overview

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.

Interventions

  • Biological Intrathecal (IT)
    Intrathecal injection of 3 ml between L4-L5
  • Biological Intravenous
    Intravenous injection via a drip

Primary outcome measures

  • NMSS [Time frame: 48]
Secondary outcome measures (1)
  • MDS-UPDRS [Time frame: 48]

Eligibility criteria

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

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
  • Neuropostep — Warsaw

Identifiers

NCT: NCT07471230 · Bio120007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗