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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02184546
Recruitment Status : Unknown
Verified August 2018 by StemGenex.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
StemGenex

Study Description
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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.

Condition or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    Participant assessment of the change in their social functioning from baseline to month 12 using the PDQUALIF social and role function subscale

  2. 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 ]
    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

  3. 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 ]
    Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep subscale

  4. 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 ]
    Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook subscale

  5. 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 ]
    Participant assessment of the change in their physical functioning from baseline to month 12 using the PDQUALIF physical functioning subscale

  6. 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 ]
    Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence subscale

  7. 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 ]
    Participant assessment of the change in their urinary function from baseline to month 12 using the PDQUALIF urinary function subscale

  8. 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 ]
    Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184546


Locations
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United States, California
StemGenex
San Diego, California, United States, 92121
Sponsors and Collaborators
StemGenex
More Information
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Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02184546    
Other Study ID Numbers: SVF01PD
ASCPD-01
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases