A Randomized, Controlled Study to Evaluate the Efficacy of Intra-articular, Autologous Adipose Tissue Injections for the Treatment of Mild-to-Moderate Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Autologous adipose tissue injection
- Conditions
- Osteoarthritis, Knee
- Sponsor
- University of Southern California
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
- Last Updated
- 6 years ago
Overview
Brief Summary
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.
Detailed Description
In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologous cells that are often referred to as "stem cells" or "MSCs" and extra-cellular matrix (ECM). Cell therapies containing ECM are thought to have the following advantages over treatments prepared using enzymatic digestion: (1) preservation of the stromal vascular niche, which allows time-release of the regenerative factors; (2) release of bioactive molecules by exosomes, which have been demonstrated to be significantly greater in mechanically processed fat than enzymatically processed fat; and (3) maintenance of the structural and morphologic unit, which is thought to increase cell efficacy by making the cells more resilient to the harsh conditions in the recipient environment. Case reports investigating the use of autologous fat treatments show promise, but a number of questions remain unanswered. Agents injected into the joint tend to be quickly cleared from the body and ECM itself has the potential to produce inflammatory signals and induce osteoarthritis. This study will use a Hyaluronic acid (HA) as an active control, which is the standard of care for pain associated with osteoarthritis. The use of HA as an active control for autologous cell-based therapies is well established and is the best option given the need to aspirate fat tissue from patients who will be receiving the study treatment.
Investigators
Thomas Vangsness
Professor of Orthopaedic Surgery
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •Age 45 to 75, inclusive
- •Normal axial alignment
- •X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
- •WOMAC-pain: Between 9 and 19, inclusive
- •Willingness to participate all scheduled follow-ups
- •Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
Exclusion Criteria
- •Pregnant or lactating
- •Intra-articular injection within 3 months of treatment
- •Inflammatory arthritis
- •Any disease or active drug use that significantly compromises coagulation
- •Significant damage and/or tears of the ACL or other supporting tissues
- •Prior knee surgery in the last 6 months in the knee that will be injected
- •Active tobacco use
- •Active alcohol or substance abuse within 6 months of study entry
- •Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
- •Knee joint infections, skin diseases or infections in the area of the injection site
Arms & Interventions
Autologous adipose tissue knee injection
Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.
Intervention: Autologous adipose tissue injection
Hyaluronic Acid knee injection
Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.
Intervention: Hyaluronic Acid
Outcomes
Primary Outcomes
The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
Time Frame: Change from baseline WOMAC score at 6 months
WOMAC-A is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain.
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)(Change from baseline in PROMIS-29 from baseline to 6 months)
- Western Ontario and McMaster Universities Osteoarthritis Index(Change from baseline in PROMIS-29 from baseline to 6 months)
- Clinical Anchors(Clinical anchors from baseline to 6 months)