Trial record 1 of 3 for:    stemgenex
Previous Study | Return to List | Next Study

Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by StemGenex
Sponsor:
Information provided by (Responsible Party):
StemGenex
ClinicalTrials.gov Identifier:
NCT02157064
First received: June 1, 2014
Last updated: June 3, 2014
Last verified: June 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 multiple sclerosis (MS). 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 MS for up to 12 months following SVF treatment.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Adipose Stromal Vascular Fraction Outcomes Research Study

Resource links provided by NLM:


Further study details as provided by StemGenex:

Primary Outcome Measures:
  • Change from Baseline on the Multiple Sclerosis Quality of Life Inventory (MSQLI) at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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 some form of multiple sclerosis
  • Subjects between the ages of 18 and 65
  • Subjects willing and able to sign informed consent
  • Subjects willing and able to perform follow up interviews and surveys

Exclusion Criteria:

  • Subjects for whom baseline data is not available
  • 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: NCT02157064

Contacts
Contact: Dawn Thorpe 800-609-7795

Locations
United States, California
StemGenex Recruiting
La Jolla, California, United States, 92037
Contact: Dawn Thorpe    800-609-7795      
Sponsors and Collaborators
StemGenex
Investigators
Principal Investigator: Jeremiah McDole, Ph.D. StemGenex
  More Information

No publications provided

Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02157064     History of Changes
Other Study ID Numbers: SVF01MS, ASCMS-01
Study First Received: June 1, 2014
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014