Parkinsonism or Parkinson's Disease Nos, Parkinsonism in Diseases Classified Elsewhere
Conditions
Keywords
mesenchymal, exosomes, parkinsonism, stem cells
Brief summary
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
BIOLOGICALIntrathecal (IT)
Intrathecal injection of 3 ml between L4-L5
BIOLOGICALIntravenous
Intravenous injection via a drip
Sponsors
Biocells Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
48 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NMSS | 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
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS | 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 |
Countries
Poland
Contacts
CONTACTAndrei Peskau
Outcome results
None listed