MSA - Multiple System Atrophy, MSA
Conditions
Keywords
MSA, Multiple System Atrophy, MSC, Mesenchimal stem cells
Brief summary
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.
Interventions
DRUGMSCs
IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period
OTHERPlacebo
Intravenous 0.9% saline infusion, volume- and appearance-matched
Sponsors
Biocells Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Multiple System Atrophy (MSA-P or MSA-C) * Age range of 35 to 65 years
Exclusion criteria
* Other major neurological disorders * Severe cardiac/renal/hepatic impairment * Prior stem cell therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Unified Multiple System Atrophy Rating Scale (UMSARS) | At week 48 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36) | At week 48 from baseline | Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36) Total Score with Range: 0-100 where 0 is the lowest value and 100 is the highest; higher scores indicate better health-related quality of life at Week 48 |
Countries
Poland
Contacts
CONTACTAndrei Peskau, M.D.
Outcome results
None listed