Clinical trial NCT02157064: Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis
Official title: Autologous Adipose Stromal Vascular Fraction Outcomes Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: StemGenex
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


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

Primary outcomes:
measure: 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)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: 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)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Fatigue Over the Course of a 12 Month Period as Measured by the Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline, Month 12
measure: 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)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Sexual Satisfaction Over the Course of a 12 Month Period as Measured by the Sexual Satisfaction Scale (SSS)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Bladder Control Over the Course of a 12 Month Period as Measured by the Bladder Control Scale (BLCS)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Bowel Control Over the Course of a 12 Month Period as Measured by the Bowel Control Scale (BWCS)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Visual Problems Over the Course of a 12 Month Period as Measured by the Impact of Visual Impairment Scale (IVIS)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Cognitive Problems Over the Course of a 12 Month Period as Measured by the Perceived Deficits Questionnaire (PDQ)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Emotional Distress Over the Course of a 12 Month Period as Measured by the Mental Health Inventory (MHI)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Social Support Over the Course of a 12 Month Period as Measured by the Modified MOS Social Support Survey (MSSS)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: StemGenex
state: California
Study officials:
References: