NCT07465198

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
55mo left

Started Sep 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

September 3, 2025

Last Update Submit

March 9, 2026

Conditions

MSA - Multiple System AtrophyMSA

Keywords

MSAMultiple System AtrophyMSCMesenchimal stem cells

Outcome Measures

Primary Outcomes (1)

  • Change in Unified Multiple System Atrophy Rating Scale (UMSARS)

    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)

    At week 48 from baseline

Study Arms (2)

MSC therapy

EXPERIMENTAL

200,000,000 cells per infusion

Drug: MSCs

Saline Solution

PLACEBO COMPARATOR

0.9% saline infusion

Other: Placebo

Interventions

MSCsDRUG

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

MSC therapy
PlaceboOTHER

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

Saline Solution

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple System Atrophy (MSA-P or MSA-C)
  • Age range of 35 to 65 years

You may not qualify if:

  • Other major neurological disorders
  • Severe cardiac/renal/hepatic impairment
  • Prior stem cell therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioCells Medical

Warsaw, Poland

Location

MeSH Terms

Conditions

Shy-Drager SyndromeMultiple System Atrophy

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersHypotensionVascular DiseasesCardiovascular DiseasesSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Andrei Peskau, M.D.

CONTACT

+48660639936info@biocellsmedical.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

March 11, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

March 1, 2031

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)