ClinicalTrials.gov record NCT07467733

Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Phase I/II Randomized Controlled Study Evaluating the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy

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 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 45 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 randomized, double-masked Phase I/II study evaluates neuroinduced mesenchymal stem cells and mesenchymal stem cell–derived exosomes in people with spinocerebellar ataxia. Participants are assigned to receive a stem-cell infusion, intranasal exosome infusion, or intranasal saline placebo. The study's main focus is safety and collecting preliminary measures of motor function over about 92 weeks.

What it is studying. The study is testing two investigational products—neuroinduced mesenchymal stem cells and mesenchymal stem cell–derived exosomes—compared with a saline placebo, to assess safety and preliminary effects on motor function. The registry lists administration routes inconsistently: exosomes and saline are described as intranasal; the cell arm is labeled intrathecal while its description states intravenous infusion. The record does not resolve that inconsistency.

What the researchers hope to learn. To evaluate safety of the investigational cell and exosome treatments and to collect preliminary measures of motor function using MDS‑UPDRS Part III and SARA as primary outcomes (with ICARS as a secondary outcome) at 92 weeks.

What this study is about

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

This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.

Interventions being studied

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

Drug
  • Intrathecal infusion
  • Intranasal infusion

Eligibility

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

Inclusion criteria

  • Clinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.

Exclusion criteria

  • Severe systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.

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 to one of three groups: a neuroinduced mesenchymal stem-cell infusion (listed as intrathecal), an intranasal infusion of mesenchymal stem-cell–derived exosomes, or an intranasal saline placebo. They will receive the assigned infusion(s) and attend regular follow-up visits with motor-function assessments using scales listed in the study (MDS‑UPDRS, SARA, ICARS) over about 92 weeks. Screening and safety checks are done before treatment and during follow-up to check for excluded conditions. Routine tests and safety monitoring will be part of participation.

How the study is structured. Randomized, double-masked, parallel Phase I/II trial with three groups (stem cells, exosomes, or saline placebo). Motor outcome measures are recorded up to 92 weeks to assess safety and preliminary signals.

Questions you could ask

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

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • 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 spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Study completion
Jun 1, 2029 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Mar 12, 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
Principal investigator
Andrei Peskau, Biocells Medical
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

investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
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.

← Back to clinical trials