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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by StemGenex
Sponsor:
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02184546
First received: July 3, 2014
Last updated: September 22, 2014
Last verified: September 2014
  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 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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


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 Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) [ 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 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:
  • 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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 Sleep at Month 12 as Measured by Participants Using the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) The Sleep Subscale [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep 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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook 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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence 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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale


Estimated Enrollment: 75
Study Start Date: July 2014
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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 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
  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: NCT02184546

Contacts
Contact: Joe Perricone 800-609-7795

Locations
United States, California
StemGenex Recruiting
La Jolla, California, United States, 92037
Sponsors and Collaborators
StemGenex
  More Information

No publications provided

Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02184546     History of Changes
Other Study ID Numbers: SVF01PD, ASCPD-01
Study First Received: July 3, 2014
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 21, 2014