Clinical trial NCT03399630: Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee
Official title: Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Osteo Arthritis Knee
Autologous Adipose Tissue
Lead sponsor: Aestique Medical Center
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind parallel groups assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety - Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
measure: Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
measure: Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
Other outcomes:
measure: Efficacy - Change in Pain Scores on the VAS Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
measure: Efficacy - Change in Function Scores on the VAS Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
measure: Efficacy - Change in Stiffness Scores on the VAS Scale at All Follow-Up Visits
timeFrame: 1 week, 6 weeks, 3 months, and 6 months
Locations:
city: Greensburg
country: United States
facility: Aestique Ambulatory Surgical Center
state: Pennsylvania
city: Greensburg
country: United States
facility: DNA Advanced Pain Treatment
state: Pennsylvania
Study officials:
affiliation: Aestique Ambulatory Surgical Center
name: Theodore Lazzaro, MD
role: PRINCIPAL_INVESTIGATOR
References: