Autologous Stem Cell Therapy in Patients With Multiple Sy... | NCT07465198

Studies
Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

NCT07465198

Sponsor

Biocells Medical

Status

Not yet recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

MSA - Multiple System Atrophy
MSA

Interventions

MSCs
Placebo

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Sep 1, 2029Estimated

Completion Date

Mar 1, 2031Estimated

First Submitted Date

Sep 3, 2025

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSC therapy	Experimental	200,000,000 cells per infusion	Drug: MSCs
Saline Solution	Placebo Comparator	0.9% saline infusion	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSCs	Drug	IV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period	MSC therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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	At week 48 from baseline

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrei Peskau, M.D.	Contact	+48660639936		info@biocellsmedical.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BioCells Medical		Warsaw			Poland	Miron Danielevich, PhD

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012791	Shy-Drager Syndrome
D019578	Multiple System Atrophy

Ancestor Terms

ID	Term
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D001480	Basal Ganglia Diseases

Browse Leaves

Not provided

Browse Branches

Not provided