Intra-articular Adipose Tissue Injections for Osteoarthritis

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.

Key facts

Study ID

NCT03242707

Run by

University of Southern California

People needed

54

Starts

2018-07-01

Expected to finish

2020-12-01

Last updated by the study team

2019-10-03

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 45 to 75, inclusive
• Normal axial alignment
• X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
• WOMAC-pain: Between 9 and 19, inclusive
• Willingness to participate all scheduled follow-ups
• Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
• BMI < 40

You may not qualify if…

• Pregnant or lactating
• Intra-articular injection within 3 months of treatment
• Inflammatory arthritis
• Any disease or active drug use that significantly compromises coagulation
• Significant damage and/or tears of the ACL or other supporting tissues
• Prior knee surgery in the last 6 months in the knee that will be injected
• Active tobacco use
• Active alcohol or substance abuse within 6 months of study entry
• Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
• Knee joint infections, skin diseases or infections in the area of the injection site
• Diabetes
• Active inhaler use
• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation

Where it is running

• Keck Medicine of USC — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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