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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399630
• Other study ID #: ATOA-01
• Status: Completed
• Phase: N/A
• Start date: August 9, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Aestique Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Injection of Autologous Adipose Tissue
Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis
• Injection of lactated ringers
Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

Locations

Country	Name	City	State
United States	Aestique Ambulatory Surgical Center	Greensburg	Pennsylvania
United States	DNA Advanced Pain Treatment	Greensburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aestique Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Safety - Incidence of Treatment-Emergent Adverse Events	Subjects will be monitored for adverse events	6 months
Secondary	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
Secondary	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
Secondary	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