Clinical trial NCT02184546: Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: StemGenex
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
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 Parkinson's disease (PD). 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 PD for up to 12 months following SVF treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for a stem cell/SVF treatment
* Subjects diagnosed with idiopathic Parkinson's disease
* Subjects ages 18 years and older
* Subjects willing and able to sign informed consent
* Subjects willing and able to perform follow up interviews and surveys

Exclusion Criteria:

* 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 Parkinson's Disease Quality of Life Questionnaire (PDQUALIF)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change from Baseline in Social and Role Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Social and Role Function Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Self Image and Sexuality at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Self Image and Sexuality Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Sleep at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Sleep Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Outlook at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Outlook Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Physical Functioning at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Physical Functioning Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Independence at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Independence Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Urinary Function at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Urinary Function Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Global Health-Related Quality of Life at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Global HRQoL Subscale
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: StemGenex
state: California
Study officials:
References: