Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by StemGenex
Sponsor:
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02157064
First received: June 1, 2014
Last updated: September 21, 2014
Last verified: September 2014
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Adipose Stromal Vascular Fraction Outcomes Research Study

Resource links provided by NLM:


Further study details as provided by StemGenex:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from Baseline in Social Support at Month 12 as Measured by Participants Using the Modified MOS Social Support Survey (MSSS)


Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02157064

Contacts
Contact: Joe Perricone 800-609-7795

Locations
United States, California
StemGenex Recruiting
La Jolla, California, United States, 92037
Contact: Joe Perricone    800-609-7795      
Sponsors and Collaborators
StemGenex
  More Information

No publications provided

Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02157064     History of Changes
Other Study ID Numbers: SVF01MS, ASCMS-01
Study First Received: June 1, 2014
Last Updated: September 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014