Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis
Autologous Adipose Stromal Vascular Fraction Outcomes Research Study
2 other identifiers
observational
221
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedAugust 31, 2018
August 1, 2018
5 years
June 1, 2014
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (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)
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.
Baseline, 12 months
Secondary Outcomes (10)
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)
Baseline, Month 12
Change from Baseline in Fatigue Over the Course of a 12 Month Period as Measured by the Modified Fatigue Impact Scale (MFIS)
Baseline, Month 12
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)
Baseline, Month 12
Change from Baseline in Sexual Satisfaction Over the Course of a 12 Month Period as Measured by the Sexual Satisfaction Scale (SSS)
Baseline, Month 12
Change from Baseline in Bladder Control Over the Course of a 12 Month Period as Measured by the Bladder Control Scale (BLCS)
Baseline, Month 12
- +5 more secondary outcomes
Eligibility Criteria
Community sample
You may qualify if:
- 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
You may not qualify if:
- Subjects for whom baseline data is not available
- Subjects with additional major health diagnoses
- Subjects that are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemGenexlead
Study Sites (1)
StemGenex
San Diego, California, 92121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2014
First Posted
June 5, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
August 31, 2018
Record last verified: 2018-08