Who may be eligible for the Stemchymal® for Polyglutamine Spinocerebellar Ataxia trial?

Inclusion Criteria: 1. Subjects are with genotypically confirmed SCA3. 2. Subjects' SARA scores are in the range of 5 to15. 3. Subjects are between 20 and 70 years of age. 4. Subjects who have signed informed consent. 5. Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing effective methods of birth control. 6. Male subjects must be practicing a medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception. Exclusion Criteria: 1. Subjects who have been enrolled in any kind of cell therapy within six months prior to screening visit (Visit 1). 2. Female subjects who have a positive pregnancy test result. 3. Subjects who have had severe vital organ diseases, including but not limited to cardiac (e.g., heart failure), liver (e.g., acute hepatic failure or chronic liver cirrhosis), lung (e.g., respiratory failure) and renal (e.g., hemodialysis or peritoneal dialysis) diseases, within six months prior to screening visit (Visit 1). 4. Subjects with immunological disorders (e.g., systemic lupus erythematosus), within six months prior to screening visit (Visit 1). 5. Subjects with other neurological disorders (e.g., Alzheimer's disease), within six months prior to screening visit (Visit 1). 6. Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit (Visit 1). 7. Subjects with any history of malignant tumors. 8. Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, schizophrenia. 9. Subjects with a Beck Depression Inventory Second Edition (BDI-II) score of over 20 points. 10. Subjects not suitable for this clinical trial according to investigator's judgment.

ClinicalTrials.gov record NCT06397274

Stemchymal® for Polyglutamine Spinocerebellar Ataxia

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

A Phase II, Randomized, Double-Blind, Placebo-controlled, Single-Center Study to Evaluate the Safety and Efficacy of Stemchymal (Allogeneic Adipose-derived Mesenchymal Stem Cells) Infusion for the Treatment of PolyQ Spinocerebellar Ataxia

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.The registry record was last updated on May 2, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.

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.

Age20 years old to 70 years old

SexAll

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, triple-masked, placebo-controlled Phase II study tests Stemchymal® infusions in people with spinocerebellar ataxias. Participants receive either intravenous Stemchymal® or placebo and are assessed over six months, with the main measure being change in SARA (Scale for the Assessment and Rating of Ataxia) score. The study also evaluates safety.

What it is studying. The study tests whether intravenous Stemchymal® infusions affect ataxia severity compared with placebo, measured by change in SARA score at 6 months.

What the researchers hope to learn. Scientific goals: evaluate the safety and therapeutic efficacy of Stemchymal® infusions in polyglutamine spinocerebellar ataxia and measure change in SARA scores at six months.

What this study is about

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

The purpose of the clinical trial is to study the therapeutic efficacy and safety of Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal® through intravenous infusion.

Interventions being studied

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

Biological: Stemchymal
Placebo

Eligibility

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

Inclusion criteria

Subjects are with genotypically confirmed SCA3.
Subjects' SARA scores are in the range of 5 to15.
Subjects are between 20 and 70 years of age.
Subjects who have signed informed consent.
Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing effective methods of birth control.
Male subjects must be practicing a medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.

Exclusion criteria

Subjects who have been enrolled in any kind of cell therapy within six months prior to screening visit (Visit 1).
Female subjects who have a positive pregnancy test result.
Subjects who have had severe vital organ diseases, including but not limited to cardiac (e.g., heart failure), liver (e.g., acute hepatic failure or chronic liver cirrhosis), lung (e.g., respiratory failure) and renal (e.g., hemodialysis or peritoneal dialysis) diseases, within six months prior to screening visit (Visit 1).
Subjects with immunological disorders (e.g., systemic lupus erythematosus), within six months prior to screening visit (Visit 1).
Subjects with other neurological disorders (e.g., Alzheimer's disease), within six months prior to screening visit (Visit 1).
Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit (Visit 1).
Subjects with any history of malignant tumors.
Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, schizophrenia.
Subjects with a Beck Depression Inventory Second Edition (BDI-II) score of over 20 points.
Subjects not suitable for this clinical trial according to investigator's judgment.

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 receive either Stemchymal® or a placebo given by intravenous infusion; the study is triple-masked (participants, caregivers, and investigators do not know the assignment). Ataxia severity will be measured using the SARA (Scale for the Assessment and Rating of Ataxia) at the start (baseline) and again at 6 months to assess change. The registry record states intravenous infusion and the 6‑month SARA outcome but does not list the exact number or timing of infusions, other visits, or additional tests and safety procedures.

How the study is structured. Interventional Phase II trial with randomized, parallel assignment and triple masking. Participants are assigned to one of two groups (Stemchymal® or placebo) and receive the assigned product by intravenous infusion. The main outcome is change in SARA score from baseline to week 24 (6 months).

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?
No sites are listed on the registry yet. Where will the study take place?
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, 2025 (estimated)
Primary completion: Jun 1, 2028 (estimated)
Study completion: Jun 1, 2028 (estimated)
Target enrollment: 20 participants (estimated)
Last updated on registry: May 2, 2024
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: Steminent US, Inc.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double-blind: Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled: A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
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.
prior to screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
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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