Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for knee osteoarthritis (OA) that occurs after a significant knee injury, known as Post-Trauma Osteoarthritis (PTOA). The researchers want to see if a single injection of a special part of fat tissue, called Stromal Vascular Fraction (SVF), can help relieve pain and improve function in the knee. The trial will involve participants who are between 18 and 45 years old and have experienced significant knee trauma or surgery in the past, have a specific level of knee pain, and have tried other treatments without success.

Eligible participants will receive the SVF injection and will be monitored for safety and effectiveness over time. It's important to note that there are specific criteria for inclusion, such as having a certain level of knee pain and being in overall good health. Participants will need to agree to attend multiple follow-up visits and provide consent for their participation. This study is currently not recruiting participants, but it aims to explore a new potential treatment option for those struggling with knee pain from previous injuries.

Gender

ALL

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