Clinical trial NCT03242707: Intra-articular Adipose Tissue Injections for Osteoarthritis
Official title: A Randomized, Controlled Study to Evaluate the Efficacy of Intra-articular, Autologous Adipose Tissue Injections for the Treatment of Mild-to-Moderate Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
timeFrame: Change from baseline WOMAC score at 6 months
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)
timeFrame: Change from baseline in PROMIS-29 from baseline to 6 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Change from baseline in PROMIS-29 from baseline to 6 months
measure: Clinical Anchors
timeFrame: Clinical anchors from baseline to 6 months
Other outcomes:
measure: Synovial fluid analysis
timeFrame: Baseline, 6 weeks and 6 months
measure: Short-term clinical evaluation - WOMAC
timeFrame: Change from baseline at 6 weeks
measure: Short-term clinical evaluation - PROMIS
timeFrame: Change from baseline at 6 weeks
measure: Force Plate Analysis
timeFrame: Assessment and change from baseline to 6 weeks and 6 months
Locations:
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
Study officials:
affiliation: Keck School of Medicine of USC
name: C.Thomas Vangsness, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.