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

NCT ID: NCT03399630

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-09
• Study Completion Date: 2018-05-31

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Injection of Autologous Adipose Tissue

Intervention Type: OTHER

Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis

Injection of Lactated Ringers

Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue

Group Type: PLACEBO_COMPARATOR

Injection of lactated ringers

Intervention Type: OTHER

Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

Interventions

Injection of Autologous Adipose Tissue

Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis

Intervention Type: OTHER

Injection of lactated ringers

Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aestique Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Lazzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Aestique Ambulatory Surgical Center

Locations

Aestique Ambulatory Surgical Center

Greensburg, Pennsylvania, United States

DNA Advanced Pain Treatment

Greensburg, Pennsylvania, United States

Countries

United States

Other Identifiers

ATOA-01

Identifier Type: -

Identifier Source: org_study_id