ClinicalTrials.gov record NCT07465198

Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Autologous Stem Cell Therapy in Patients With Multiple System Atrophy

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age35 years old to 65 years old
SexAll
LocationPoland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase II randomized, double-blind, placebo-controlled trial tests autologous mesenchymal stem-cell (MSC) infusions in people with Multiple System Atrophy (MSA). Participants are assigned to receive an IV infusion of MSCs or a saline placebo and are followed to assess function and quality of life. Outcomes include change in the Unified Multiple System Atrophy Rating Scale (UMSARS) and a health-related quality-of-life measure at 48 weeks.

What it is studying. Whether an IV infusion of autologous neuroinduced mesenchymal stem cells changes motor and functional outcomes and quality of life compared with placebo in people with MSA.

What the researchers hope to learn. To evaluate the safety and efficacy of autologous MSC therapy in MSA and to measure change in disease severity (UMSARS) and health-related quality of life (SF-36) at 48 weeks.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • MSCs
Other
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned (double‑blind) to receive either an IV infusion of 200,000,000 neuroinduced mesenchymal stem cells (MSC) or a matching saline placebo. The infusion is given at week 1 and participants are followed with clinical assessments through week 48, including the Unified Multiple System Atrophy Rating Scale (UMSARS) and the SF‑36 quality‑of‑life questionnaire. Visits will include clinical exams and questionnaires; the registry does not list other specific procedures or sample collections.

How the study is structured. Participants are randomly assigned, and neither participants nor investigators know who receives which treatment (double-blind). One group receives a single IV infusion of 200,000,000 neuroinduced mesenchymal stem cells at week 1; the other receives a volume- and appearance-matched saline placebo. Participants are followed and assessed up to 48 weeks to measure symptoms and quality of life.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Poland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Study completion
Mar 1, 2031 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Mar 11, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Biocells Medical

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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