ANTI-SCARRING AND ANTI-INFLAMMATORY EFFECTS OF AMNIOTIC MEMBRANE EXTRACTS

DESCRIPTION (provided by applicant): Due to the Pi's pioneering work over the past decade, amniotic membrane transplantation (AMT) for ocular surface reconstruction was approved by the FDA in 2001 and reimbursed by Medicare in 2004 as a standard surgical procedure. A number of studies have shown that AMT is effective in facilitating epithelial wound healing and reducing stromal inflammation, scarring and unwanted new blood vessel formation. Using the Pi's proprietary method, Bio-Tissue (a subsidiary of TissueTech, Inc.) has distributed more than 10,000 human amniotic membrane products (trademark name: "AmnioGraft") to more than 1,200 ophthalmic surgeons worldwide since 1997. Nevertheless, the AmnioGraft transplantation procedure requires the use of sutures and surgery in an operating room. Previously, we developed a "sutureless" AmnioGraft and received FDA's 510(k) approval for this as a Class II device (2003), trademarked as Prokera, as a first step toward achieving our ultimate objective of performing AMT without sutures to reduce the medical cost and facilitate the ease of patient care, especially for those patients suffering from severe ocular surface destruction such as Stevens Johnson syndrome and chemical burns. In this Phase I application, we present preliminary data to support the feasibility of verifying anti-scarring and anti-inflammatory effects in both water-soluble and lyophilized powder of AM extracts based on our newly reported in vitro assays of TGF-b promoter activity and macrophage apoptosis, respectively. We thus propose another novel approach of delivering AM's inherent anti-inflammatory and anti-scarring effects without being restricted by the sheet configuration of AmnioGraft or Prokera. We would like to compare the relative potency of using collagen or hyaluronic acid as a vehicle to deliver such effects of these two different AM extracts (Aim 1), and to identify the molecular component(s) that is responsible for most, if not all, anti-scarring and anti-inflammatory effects observed in AM stroma (Aim 2). Successful completion of these two aims will allow us to gather critical data for pre-clinical animal testing during the Phase II. We believe that these new technologies will generate new therapeutics to deliver AM's inherent anti-scarring and anti-inflammatory effects to any body site, and help expand our market potential not only in ophthalmology but also in other medical and surgical subspecialties whenever suppressing of tissue inflammation and scarring becomes necessary.