Recruiting

Adipose Stem Cells

Sponsor:

StemGenex

Code:

NCT02241408

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 joint pain and functionality in people with Osteoarthritis (OA). SVF contains components with "regenerative" properties, including stem cells that have shown promise for ameliorating specific disease conditions. This study is designed to evaluate joint pain and functionality changes in individuals with OA for up to 12 months following SVF treatment.

Conditions

Osteoarthritis

Study ID

NCT02241408

Start date

Sep, 2014

Status verified date

Aug, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Fluent in English
  • Over the age of 18
  • Diagnosed with OA of the knee and/or hip
  • Scheduled for intravenous and intra-articular administrations of autologous SVF
  • Capable of understanding and willing to sign informed consent
  • Willing and able to complete brief phone interviews
  • Willing and able to complete online surveys

Exclusion Criteria:

  • Co-morbidity with an autoimmune disorder
  • Pregnant, may become pregnant, or breastfeeding
  • Subjects for which baseline data is not available

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change from Baseline in Overall Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) [ Time Frame: Baseline, 12 months ]
  • Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Holly Bergen

800-609-7795

Locations

StemGenex

Recruiting

San Diego, California, United States, 92121

Contacts

855-742-7836

More Information

Sponsor

StemGenex

Last update posted

Aug 31, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by StemGenex on 2018-08-31.