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NCT Number: NCT07465198

Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

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.

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Key information

Conditions

MSA - Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension MSA Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Primary Dysautonomias Shy-Drager Syndrome Synucleinopathies Vascular Diseases

Age range

35 year–65 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

  • 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

Treatment and study plan

MSCs

Drug

IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period

Placebo

Other

Intravenous 0.9% saline infusion, volume- and appearance-matched

Primary outcomes

  1. Change in Unified Multiple System Atrophy Rating Scale (UMSARS)

    Time frame: At week 48 from baseline

Secondary outcomes

  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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei Peskau, M.D.

CONTACT

[email protected]

+48660639936

Sponsors and collaborators

Lead sponsor

Biocells Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Mar 11, 2026
Registry last updated
Mar 11, 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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