ClinicalTrials.gov
A service of the U.S. National Institutes of Health
Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis
This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by StemGenex
Sponsor:
StemGenex
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02157064
First received: June 1, 2014
Last updated: June 17, 2015
Last verified: June 2015
History of Changes
Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record
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:
Genetics Home Reference related topics: multiple sclerosis
MedlinePlus related topics: Multiple Sclerosis
U.S. FDA Resources
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
Contact: Centrila McGee 800-609-7795
A service of the U.S. National Institutes of Health
Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis
This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by StemGenex
Sponsor:
StemGenex
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02157064
First received: June 1, 2014
Last updated: June 17, 2015
Last verified: June 2015
History of Changes
Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record
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:
Genetics Home Reference related topics: multiple sclerosis
MedlinePlus related topics: Multiple Sclerosis
U.S. FDA Resources
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
Contact: Centrila McGee 800-609-7795