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

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Other: Injection of Autologous Adipose Tissue; Other: Injection of lactated ringers

• Registration Number: NCT03399630
• Lead Sponsor: Aestique Medical Center

Brief Summary

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

Detailed Description

This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.

Study Timeline

• Study Start: 2016-08-09
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-16
• Primary Completion: 2018-02-28
• Study Completion: 2018-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. 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.
2. 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.
3. Males and females 40-75 years old.
4. Participants will be in good health (ASA Class I-II) with a BMI < 35.
5. Continued pain in the knee despite conservative therapies for at least 6 months.
6. Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
7. Must speak, read and understand English.
8. Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria

1. Participants who have had surgery of either knee within 6 months prior to the screening visit.
2. Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
3. Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
4. 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.
5. Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
6. Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
7. Participants that are allergic to lidocaine, epinephrine or valium
8. History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
9. Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of Autologous Adipose Tissue	Injection of Autologous Adipose Tissue	Treatment knee receives injection of 1.5 cc's of adipose tissue mixed with 1.5 cc's of Lactated Ringers
Injection of Lactated Ringers	Injection of lactated ringers	Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue

Primary Outcome Measures

Name	Time	Method
Safety - Incidence of Treatment-Emergent Adverse Events	6 months	Subjects will be monitored for adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits	1 week, 6 weeks, 3 months, and 6 months	Patient outcomes for pain will be recorded
Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits	1 week, 6 weeks, 3 months, and 6 months	Patient outcomes for function will be recorded
Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits	1 week, 6 weeks, 3 months, and 6 months	Patient outcomes for stiffness will be recorded

Trial Locations

Locations (2)

DNA Advanced Pain Treatment; 🇺🇸 Greensburg, Pennsylvania, United States

Aestique Ambulatory Surgical Center; 🇺🇸 Greensburg, Pennsylvania, United States