Trial record 2 of 3 for:    stemgenex

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by StemGenex
Sponsor:
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02184546
First received: July 3, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  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 on the Parkinson's Disease Quality of Life Questionnaire (PDQUALIF) at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

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: July 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014