Stormal Vascular Fraction
Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Stromal vascular fraction (SVF) cells contain high concentrations of regenerative mesenchymal stem cells (MSC), as well as cells with anti-inflammatory properties such as T regulatory cells and alternatively activated macrophages. SVF administration has been successfully used in preclinical and veterinary studies to treat osteoarthritis (OA), as well as in pilot clinical trials. Unfortunately, to date, no study has been conducted using a defined patient population in a clinic-based setting.
The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the 20 patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra- articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space.
The purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- Age >18 years and ability to understand the planned treatment.
- Subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren–Lawrence classification
- Ability and willingness to undergo liposuction
- Signed Informed Consent document
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears (“bucket handle” tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or postinfectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age. Intraarticular corticosteroid injection within the previous 3 months.
- A major neurologic deficit.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy