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Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02157064
First Posted: June 5, 2014
Last Update Posted: September 1, 2017
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.
Information provided by (Responsible Party):
StemGenex
  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 ]
    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 ]
    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)


Enrollment: 220
Study Start Date: May 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157064


Locations
United States, California
StemGenex
La Jolla, California, United States, 92037
Sponsors and Collaborators
StemGenex
  More Information

Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02157064     History of Changes
Other Study ID Numbers: SVF01MS
ASCMS-01 ( Other Identifier: StemGenex )
First Submitted: June 1, 2014
First Posted: June 5, 2014
Last Update Posted: September 1, 2017
Last Verified: August 2017

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