ClinicalTrials.gg
Not yet recruitingNCT07465198Updated Mar 11, 2026

Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

A Phase 2 interventional study of MSCs and Placebo in MSA - Multiple System Atrophy and MSA, sponsored by Biocells Medical. Not yet recruiting at 1 site in Poland. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Biocells Medical · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • MSA - Multiple System Atrophy
  • MSA

Keywords

  • MSA
  • Multiple System Atrophy
  • MSC
  • Mesenchimal stem cells
03

In context

Shy-Drager Syndrome

33 studies on the registry are indexed under Shy-Drager Syndrome; 15 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 24 interventional studies indexed under Shy-Drager Syndrome.

Browse Shy-Drager Syndrome studies →

Lead sponsor

Biocells Medical is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other major neurological disorders
  • Severe cardiac/renal/hepatic impairment
  • Prior stem cell therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    MSC therapy

    200,000,000 cells per infusion

    Drug: MSCs

  • Placebo comparator
    Saline Solution

    0.9% saline infusion

    Other: Placebo

Interventions

  • DrugMSCs

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

  • OtherPlacebo

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

06

What researchers measure

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)

    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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2025
First posted
Mar 11, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2029
CompletionEst.
Mar 1, 2031
Last update
Mar 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07465198
Lead sponsor
Biocells Medical
Responsible party
Sponsor
First posted
Mar 11, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Mar 1, 2031 (estimated)
Last update
Mar 11, 2026

Study contacts

Andrei Peskau, M.D.
Contact
info@biocellsmedical.com
+48660639936

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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