Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT02157064
• Recruitment Status: Unknown
• First Posted: June 5, 2014
• Last Update Posted: August 31, 2018
• Sponsor: StemGenex
• Information provided by (Responsible Party): StemGenex

Study Description

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.

Condition or disease
Multiple Sclerosis

Study Design

• Study Type: Observational
• Actual Enrollment: 221 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Autologous Adipose Stromal Vascular Fraction Outcomes Research Study
• Study Start Date: May 2014
• Estimated Primary Completion Date: May 2019
• Estimated Study Completion Date: May 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

Locations

United States, California

StemGenex

San Diego, California, United States, 92121

Sponsors and Collaborators

StemGenex

More Information

• Responsible Party: StemGenex
• ClinicalTrials.gov Identifier: NCT02157064
• Other Study ID Numbers: SVF01MS; ASCMS-01 ( Other Identifier: StemGenex )
• First Posted: June 5, 2014
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases