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

Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial

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

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Other: Injection of Autologous Adipose Tissue; Other: Injection of lactated ringers

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • Aestique Ambulatory Surgical Center
    • Greensburg, Pennsylvania, United States, 15601
      • DNA Advanced Pain Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Injection of Autologous Adipose Tissue; Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis
Placebo Comparator: Injection of Lactated Ringers; Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue	Other: Injection of lactated ringers; Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Incidence of Treatment-Emergent Adverse Events	Subjects will be monitored for adverse events	6 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aestique Medical Center
• Investigators: Principal Investigator: Theodore Lazzaro, MD, Aestique Ambulatory Surgical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Osteo Arthritis Knee; Autologous Adipose Tissue
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ATOA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No