The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Peter Fodor, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $50,000

Project Name: Adipose Derived Stromal Cell (ADSC) Injections 

Project Summary: Osteoarthritis (OA) of the knee results from degeneration of the cartilage in the knee and is the most common musculoskeletal disorder (Buckwalter and Martin, 2006).  Causes of OA include age, heredity, injury, excessive exercise, obesity, and disease, and occurrence is expected to increase exponentially as the world population ages and obesity increases (Dunlop et al., 2003).  At present treatment of OA may include medication to control pain, injection of corticosteroids to reduce inflammation, or injection of viscosupplements based on hyaluronic acid.  None of these treatment types reverse or repair the degenerative nature of the disease (Coleman, 2010).  Regenerative cell therapy uses the anti-inflammatory and healing properties of a patient’s own cells to treat inflamed and painful tissues.  Recent studies on animal and human subjects have shown the efficacy of adipose-derived stem and stromal vascular fraction cells to decrease inflammation and pain and to increase the range of motion in joints (Black et al., 2007; Davatchi et al., 2011; Koh et al., 2013; Orozco et al., 2013; Pak et al., 2013; Peeters et al., 2013; Wakitani et al., 2002).

Regenerative cells that may be derived from adipose tissue include the Stromal Vascular Fraction (SVF) cell which is a heterogeneous reparative cell population (Lin, 2009; Lindoos et al., 2010; Tholpady et al., 2006; Yoshimura et al., 2010).  The adipose-derived SVF cells are readily obtained from human lipoaspirate samples using enzymatic digestion to separate the SVF cells from the extracellular matrix and the adipocytes.  The stromal vascular fraction obtained from adipose tissue has been characterized by flow cytometry and contains a mesenchymal stem cell compartment (MSC) (6.7%), an endothelial precursor cell compartment (EPC) (2%) and a monocyte/macrophage compartment (10%) (Mitchell et al., 2006; Riordan, 2009; Varma et al., 2007). Differences in cytometric assessment result from use of different isolation techniques, different cell surface markers, and/or different gating strategies for the flow cytometer.  The SVF does not include any mature adipocytes (floating cells).  Only non-floating mono-nucleated cells are counted in the SVF and the counting method used to assay the SVF needs to be capable of accurately excluding RBC’s and other non-viable small debris fragments, RBCs, and oil droplets.  

In this paper we describe use of autologous adipose-derived SVF to treat OA in 11 knees of 6 patients (5 patients with bilateral OA and 1 patient with unilateral disease) with initial pain evaluated at 4 or greater on a 10 point scale.  Our objective with this pilot study was to evaluate the safety of SVF injection for OA of the knee as well as initial potential clinical changes resulting from injection of the SVF.  This clinical study was submitted for IRB review and approval (IntegReview, Austin, TX, USA).  The study is listed on the clinical trials.gov website, number NCT02357485.