Clinical trial NCT05515523: Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)
Official title: Pilot Trial of Intra-articular Stromal Vascular Fraction for the Treatment of Knee Post-Trauma Osteoarthritis and Biomarker Identification
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Osteoarthritis
Keywords: degenerative joint disease
degenerative arthritis
Knee trauma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).

Detailed description: Clinical treatment generally involves a life-long combination of exercise, lifestyle modifications, and/or analgesics. If pain becomes debilitating, different surgical options exist, including arthroscopic joint debridement and mechanical axis change through osteotomies around the knee and eventually joint replacement surgery for severe cases to improve the quality of life. However, patients under 40 years of age, who expect to continue an active lifestyle, have only a 40% "good or excellent" function score after total knee replacement, they are most likely to outlive their initial replacement and need revision.

Eligibility criteria: Inclusion Criteria:

* Males and females 18 - 45 with a preceding history (\>1 and \< 20 years ago) of significant knee trauma or trauma- related knee surgery
* Post-Trauma Osteoarthritis (PTOA) as diagnosed by K-L Grade II or III OA (weight bearing X-ray) and physician review
* Subjects must present with symptomatic (injured knee) visual analog scale (VAS) pain \> 4. If bilateral disease, Knee Osteoarthritis (KOA) pain in the other knee must be less than/equal to 3 on the VAS for pain
* Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of \> 25 and \<90
* Study Subjects must have continued knee pain despite at least two conservative prescribed therapies (pain medications, physical therapy, knee injections, or weight loss), spanning a period of at least 3 months
* Study Subjects 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
* Subjects will be in good health (ASA Class I-II) with a Body mass index (BMI) \< 35
* Subjects must speak, read, and understand English
* Subjects must be reasonably able to return for multiple follow-up visits, to include procedure visits

Exclusion Criteria:

* Subjects whose knee pain is caused by, (i) diffuse edema, (ii) cartilage lesion greater than 1 cm width and grade 4 depth by MRI or (iii) osteochondritis dissecans
* Subjects who have had surgery of either knee within 12 months prior to the screening visit
* Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation, stem cells, or platelet rich plasma (PRP)
* Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, or neurogenic or vascular claudication
* Subjects who have symptomatic Osteoarthritis (OA) of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
* Subjects that are unwilling to stop taking prescription or over the counter pain and anti-inflammatory medication for 7 days prior to any visit
* Subjects that are allergic to lidocaine, epinephrine, or valium or other sedatives
* Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped prior to IA injection
* Subjects with systemic immunosuppressant use within six (6) weeks from screening
* Subjects with human immunodeficiency virus (HIV)/viral hepatitis B or human T-lymphotropic virus type 1 (C/HTLV)
* Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
* Subjects that use any form of tobacco
* Women that are pregnant or planning to become pregnant during the study
* Subjects on long term use of oral steroids or disease-modifying anti-rheumatic drugs
* History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site
* Subjects currently on worker's compensation

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Year 1
Secondary outcomes:
Other outcomes:
measure: Knee Pain scores - Visual Analog Scale (VAS)
timeFrame: Baseline, Month 1, Month 3, Month 6, and Year 1
measure: Knee Pain scores - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, Month 1, Month 3, Month 6, and Year 1
measure: Synovial Fluid Inflammatory Biomarker measurements
timeFrame: Baseline, Month 1, Month 3, Month 6, and Year 1
measure: General Health scores - Patient-Reported Outcomes Measurement Information System (PROMIS 29)
timeFrame: Baseline, Month 1, Month 3, Month 6, and Year 1
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Claude T Moorman, MD
role: PRINCIPAL_INVESTIGATOR
References: