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

August 28, 2018 updated by: StemGenex
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • StemGenex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12
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
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
StemGenex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVF01PD
  • ASCPD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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