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Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis

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: NCT02157064
Recruitment Status : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
StemGenex

Tracking Information
First Submitted Date June 1, 2014
First Posted Date June 5, 2014
Last Update Posted Date August 31, 2018
Study Start Date May 2014
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2014)
Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI) [ Time Frame: Baseline, 12 months ]
The change from baseline over the course of 12 months using participants' assessment of their quality of life. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a multiple point Likert scale.
Original Primary Outcome Measures
 (submitted: June 3, 2014)
Change from Baseline on the Multiple Sclerosis Quality of Life Inventory (MSQLI) at 12 months [ Time Frame: Baseline, 12 months ]
Change History Complete list of historical versions of study NCT02157064 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 21, 2014)
  • Change from Baseline in Overall General Quality of Life Over the Course of a 12 Month Period as Measured by the Health Status Questionnaire (SF-36) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in General Quality of Life at Month 12 as Measured by Participants Using the Health Status Questionnarie (SF-36)
  • Change from Baseline in Fatigue Over the Course of a 12 Month Period as Measured by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Fatigue at Month 12 as Measured by Participants Using the Modified Fatigue Impact Scale (MFIS)
  • Change from Baseline in Pain and Other Sensory Symptoms Over the Course of a 12 Month Period as Measured by the MOS Pain Effects Scale (PES) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Pain and Other Sensory Symptoms at Month 12 as Measured by Participants Using the MOS Pain Effects Scale (PES)
  • Change from Baseline in Sexual Satisfaction Over the Course of a 12 Month Period as Measured by the Sexual Satisfaction Scale (SSS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Sexual Satisfaction at Month 12 as Measured by Participants Using the Sexual Satisfaction Scale (SSS)
  • Change from Baseline in Bladder Control Over the Course of a 12 Month Period as Measured by the Bladder Control Scale (BLCS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Bladder Control at Month 12 as Measured by Participants Using the Bladder Control Scale (BLCS)
  • Change from Baseline in Bowel Control Over the Course of a 12 Month Period as Measured by the Bowel Control Scale (BWCS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Bowel Control at Month 12 as Measured by Participants Using the Bowel Control Scale (BWCS)
  • Change from Baseline in Visual Problems Over the Course of a 12 Month Period as Measured by the Impact of Visual Impairment Scale (IVIS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Visual Problems at Month 12 as Measured by Participants Using the Impact of Visual Impairment Scale (IVIS)
  • Change from Baseline in Cognitive Problems Over the Course of a 12 Month Period as Measured by the Perceived Deficits Questionnaire (PDQ) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Cognitive Problems at Month 12 as Measured by Participants Using the Perceived Deficits Questionnaire (PDQ)
  • Change from Baseline in Emotional Distress Over the Course of a 12 Month Period as Measured by the Mental Health Inventory (MHI) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Emotional Distress at Month 12 as Measured by Participants Using the Mental Health Inventory (MHI)
  • Change from Baseline in Social Support Over the Course of a 12 Month Period as Measured by the Modified MOS Social Support Survey (MSSS) [ Time Frame: Baseline, Month 12 ]
    Change from Baseline in Social Support at Month 12 as Measured by Participants Using the Modified MOS Social Support Survey (MSSS)
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis
Official Title Autologous Adipose Stromal Vascular Fraction Outcomes Research Study
Brief Summary The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with multiple sclerosis (MS). SVF contains components with "regenerative" properties, including stem cells that may be capable of ameliorating specific disease conditions. This study is designed to evaluate quality of life changes in individuals with MS for up to 12 months following SVF treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Active, not recruiting
Actual Enrollment
 (submitted: August 28, 2018)
221
Original Estimated Enrollment
 (submitted: June 3, 2014)
100
Estimated Study Completion Date May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects scheduled for a stem cell/SVF treatment
  • Subjects diagnosed with some form of multiple sclerosis
  • Subjects between the ages of 18 and 65
  • Subjects willing and able to sign informed consent
  • Subjects willing and able to perform follow up interviews and surveys

Exclusion Criteria:

  • Subjects for whom baseline data is not available
  • Subjects with additional major health diagnoses
  • Subjects that are pregnant or breastfeeding
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02157064
Other Study ID Numbers SVF01MS
ASCMS-01 ( Other Identifier: StemGenex )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party StemGenex
Study Sponsor StemGenex
Collaborators Not Provided
Investigators Not Provided
PRS Account StemGenex
Verification Date August 2018