Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

March 9, 2026 updated by: Biocells Medical

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSC therapy
200,000,000 cells per infusion
Drug: MSCs
IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period
Placebo Comparator: Saline Solution
0.9% saline infusion
Other: Placebo
Intravenous 0.9% saline infusion, volume- and appearance-matched

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Time Frame: At week 48 from baseline
At week 48 from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 48 from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocells Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio120004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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