CClinicalTrials.gg
Not yet recruitingNCT06397274Updated May 2, 2024

Stemchymal® for Polyglutamine Spinocerebellar Ataxia

A Phase 2 interventional study of Stemchymal and Placebo in Spinocerebellar Ataxias, sponsored by Steminent US, Inc.. Not yet recruiting. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Steminent US, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Stemchymal®

    Biological: Stemchymal

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalStemchymal

    Patients will receive Stemchymal® through intravenous infusion

  • BiologicalPlacebo

    Patients will receive Placebo through intravenous infusion

05

What researchers measure

Primary outcomes

  1. Change of Scale for the Assessment and Rating of Ataxia (SARA) scores from baseline (week 0) at 6 months (week 24).

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06397274
Lead sponsor
Steminent US, Inc.
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
May 2, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion