Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

Phase 2Not Yet RecruitingNCT07465198

Biocells Medical50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

MSA - Multiple System Atrophy MSA

Interventions

MSCsDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

BioCells Medical

Warsaw, Poland

Outcomes

Primary Outcomes

Change in Unified Multiple System Atrophy Rating Scale (UMSARS)

Time frame: At week 48 from baseline

Secondary Outcomes

Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36)

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

Time frame: At week 48 from baseline

Central Contacts

Andrei Peskau, M.D.

CONTACT

+48660639936 info@biocellsmedical.com

Data from ClinicalTrials.gov

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