Stemchymal® for Polyglutamine Spinocerebellar Ataxia
ConditionSpinocerebellar Ataxias
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-70
SponsorSteminent US, Inc.
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
Qualifiers
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
Treatments tested in this trial
- Stemchymal
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov