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Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540655
Recruitment Status : Unknown
Verified October 2016 by Steminent Biotherapeutics Inc..
Recruitment status was:  Recruiting
First Posted : September 4, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Steminent Biotherapeutics Inc.

Tracking Information
First Submitted Date  ICMJE August 26, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
To assess the changes from the baseline to all visits on Scale for the Assessment and Rating of Ataxia (SARA) score. [ Time Frame: 14 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • To assess the safety by incidence of adverse events, changes of vital signs, blood biochemistry tests, complete blood count, immunoactivity assay, urinalysis and magnetic resonance imaging (MRI). [ Time Frame: 14 months ]
  • To assess the changes from the baseline to all visits on SCA functional index (SCAFI) [ Time Frame: 14 months ]
  • To assess the changes from the baseline to all visits on sensory organization test (SOT) [ Time Frame: 14 months ]
    Balance test
  • To assess the changes from the baseline to all visits on inventory of non-ataxia signs (INAS) [ Time Frame: 14 months ]
  • To assess the changes from the baseline to all visits on clinical global impression (CGI) [ Time Frame: 14 months ]
  • To assess the changes from the baseline to all visits on patient global impression of improvement (PGI-I) [ Time Frame: 14 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia
Official Title  ICMJE A Phase II, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety and Efficacy of Stemchymal® Infusion for the Treatment of Polyglutamine Spinocerebellar Ataxia
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebellar Ataxia
Intervention  ICMJE
  • Biological: Stemchymal®
    Patients will receive Stemchymal® through intravenous infusion
  • Procedure: Excipients
    Patients will receive excipients through intravenous infusion
Study Arms  ICMJE
  • Experimental: Stemchymal®
    Infusion of Stemchymal®
    Intervention: Biological: Stemchymal®
  • Placebo Comparator: Vehicle
    Infusion of excipients
    Intervention: Procedure: Excipients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects are with genotypically confirmed spinocerebellar ataxia type 2 or spinocerebellar ataxia type 3.
  2. Subjects' baseline SARA score are in the range of 8 to15.
  3. Subjects are between 20 and 70 years of age.
  4. Subjects who had signed informed consent.

Exclusion Criteria:

  1. Subjects had been enrolled in any kind of cell therapy within six months prior to screening visit.
  2. Females with a positive pregnancy test result.
  3. Subjects who had had severe vital organ disease as diagnosed, including but not limited to cardiac (ex. heart failure), liver (ex. acute hepatic failure or chronic liver cirrhosis), lung (ex. respiratory failure) and renal (ex. hemodialysis or peritoneal dialysis) insufficiency, within six months prior to screening visit.
  4. Subjects with immunological disorders (ex. Systemic lupus erythematosus), within six months prior to screening visit.
  5. Subjects with other neurological disorders (ex. Alzheimer's disease), within six months prior to screening visit.
  6. Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit.
  7. Subjects with any history of malignancy tumors.
  8. Subjects with a history of hypersensitivity/allergy to penicillin.
  9. Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, and schizophrenia.
  10. Subjects with Beck Depression Inventory Second Edition (BDI-II) score over 20 points.
  11. Subjects with unstable illnesses or contraindication for this clinical trial according to PI's judgment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540655
Other Study ID Numbers  ICMJE IB02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steminent Biotherapeutics Inc.
Study Sponsor  ICMJE Steminent Biotherapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Steminent Biotherapeutics Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP