Osteoarthritis, Knee
Conditions
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.
Interventions
BIOLOGICALAutologous adipose tissue injection
20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue. The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.
DRUGHyaluronic Acid
Synvisc-One® is a high molecular weight sodium hyaluronate.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients will know which group they have been assigned to
Intervention model description
Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 45 to 75, inclusive 2. Normal axial alignment 3. X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive 4. WOMAC-pain: Between 9 and 19, inclusive 5. Willingness to participate all scheduled follow-ups 6. Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study 7. BMI \< 40
Exclusion criteria
1. Pregnant or lactating 2. Intra-articular injection within 3 months of treatment 3. Inflammatory arthritis 4. Any disease or active drug use that significantly compromises coagulation 5. Significant damage and/or tears of the ACL or other supporting tissues 6. Prior knee surgery in the last 6 months in the knee that will be injected 7. Active tobacco use 8. Active alcohol or substance abuse within 6 months of study entry 9. Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations 10. Knee joint infections, skin diseases or infections in the area of the injection site 11. Diabetes 12. Active inhaler use 13. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29) | Change from baseline in PROMIS-29 from baseline to 6 months | A collection of 4-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. |
| Western Ontario and McMaster Universities Osteoarthritis Index | Change from baseline in PROMIS-29 from baseline to 6 months | WOMAC 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, stiffness, and physical functioning of the joints. |
| Clinical Anchors | Clinical anchors from baseline to 6 months | Clinical anchors will be used to identify minimal important differences in treatment groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Synovial fluid analysis | Baseline, 6 weeks and 6 months | Selected OA biomarker profiles that define different OA phenotypes predict the responses to autologous adipose tissue injections |
| Short-term clinical evaluation - WOMAC | Change from baseline at 6 weeks | WOMAC questionnaire will be administered at the 6-week follow-up |
| Short-term clinical evaluation - PROMIS | Change from baseline at 6 weeks | PROMIS questionnaire will be administered at the 6-week follow-up |
| Force Plate Analysis | Assessment and change from baseline to 6 weeks and 6 months | Balance will be assessed using a proprietary force plate system at baseline, 6 weeks and 6 months. |
Countries
United States
Contacts
Primary ContactWilliam Fang
Outcome results
None listed