Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee

Completed · Not applicable · Has a placebo group

Conditions studied: Osteo Arthritis Knee

In brief

Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.

Key facts

Study ID

NCT03399630

Run by

Aestique Medical Center

People needed

8

Starts

2016-08-09

Expected to finish

2018-05-31

Last updated by the study team

2018-06-26

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
• Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
• Males and females 40-75 years old.
• Participants will be in good health (ASA Class I-II) with a BMI < 35.
• Continued pain in the knee despite conservative therapies for at least 6 months.
• Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
• Must speak, read and understand English.
• Subjects must be reasonably able to return for multiple follow-up visits.

You may not qualify if…

• Participants who have had surgery of either knee within 6 months prior to the screening visit.
• Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
• Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
• Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
• Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
• Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
• Participants that are allergic to lidocaine, epinephrine or valium
• History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
• Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months

Where it is running

• Aestique Ambulatory Surgical Center — Greensburg, Pennsylvania, United States
• DNA Advanced Pain Treatment — Greensburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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