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Not yet recruiting NCT07465198

Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

Phase II Interventional MSA - Multiple System Atrophy MSA

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: MSCs, Placebo.
Who it may be relevant to
Registry conditions: MSA - Multiple System Atrophy, MSA. Basic parameters: 35 years — 65 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

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

Overview

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

  • Drug MSCs
    IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period
  • Other Placebo
    Intravenous 0.9% saline infusion, volume- and appearance-matched

Primary outcome measures

  • Change in Unified Multiple System Atrophy Rating Scale (UMSARS) [Time frame: At week 48 from baseline]
Secondary outcome measures (1)
  • Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36) [Time frame: At week 48 from baseline]

Eligibility criteria

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

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
  • BioCells Medical — Warsaw

Identifiers

NCT: NCT07465198 · Bio120004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗