Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease

• Conditions: Parkinson's Disease

• Registration Number: NCT02184546
• Lead Sponsor: StemGenex

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	Baseline, 12 months	The change from baseline over the course of 12 months using participants' assessment of their overall 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 according to one of seven various five-point Likert response scales.

Secondary Outcome Measures

Name	Time	Method
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	Baseline, Month 12	Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep subscale
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	Baseline, Month 12	Participant assessment of the change in their physical functioning from baseline to month 12 using the PDQUALIF physical functioning subscale
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	Baseline, Month 12	Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence subscale
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	Baseline, Month 12	Participant assessment of the change in their social functioning from baseline to month 12 using the PDQUALIF social and role function subscale
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	Baseline, Month 12	Participant assessment of the change in their self image and sexual functioning from baseline to month 12 using the PDQUALIF self image and sexuality subscale
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	Baseline, Month 12	Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook subscale
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	Baseline, Month 12	Participant assessment of the change in their urinary function from baseline to month 12 using the PDQUALIF urinary function subscale
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	Baseline, Month 12	Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale

Trial Locations

Locations (1)

StemGenex; 🇺🇸 San Diego, California, United States