Parkinson's DiseaseNCT02184546
Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease
An observational study of Parkinson's Disease, run by StemGenex at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- 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
Who cannot join
- Subjects with additional major health diagnoses
- Subjects that are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Baseline, 12 months
Secondary outcomes (8)
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
Participant assessment of the change in their social functioning from baseline to month 12 using the PDQUALIF social and role function subscale
Measured: 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
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
Measured: 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
Participant assessment of the change in their sleep quality from baseline to month 12 using the PDQUALIF sleep subscale
Measured: 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
Participant assessment of the change in their life outlook from baseline to month 12 using the PDQUALIF outlook subscale
Measured: 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
Participant assessment of the change in their physical functioning from baseline to month 12 using the PDQUALIF physical functioning subscale
Measured: 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
Participant assessment of the change in their feeling of independence from baseline to month 12 using the PDQUALIF independence subscale
Measured: 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
Participant assessment of the change in their urinary function from baseline to month 12 using the PDQUALIF urinary function subscale
Measured: 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
Participant assessment of the change in their overall health-related quality of life from baseline to month 12 using the PDQUALIF global HRQoL subscale
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- StemGenex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184546
- Sponsor's protocol ID
- SVF01PD
- Other IDs
- ASCPD-01
- Status last verified
- Aug 2018
- First submitted
- 3 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Data of Adipose Stem Cells to Treat Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02184546
- Acronym / sponsor ID
- SVF01PD
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- StemGenexIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with additional major health diagnoses
- Subjects that are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by StemGenex at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.