About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Stemchymal
Biological/VaccinePatients will receive Stemchymal® through intravenous infusion
Placebo
Biological/VaccinePatients will receive Placebo through intravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
Change of Scale for the Assessment and Rating of Ataxia (SARA) scores from baseline (week 0) at 6 months (week 24).
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: