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

Wake Forest University (WFU)

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Osteoarthritis

Treatments

Genetic: Adipose Derived (AD) Stromal Vascular Fraction (SVF)

Study type

Interventional

Funder types

Other

Identifiers

NCT05515523

IRB00088231

Details and patient eligibility

About

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).

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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