More than 16 million Americans have diabetes and nearly 750,000 cases are reported every year. Insulin Dependent Diabetes Mellitus occurs most often in children and young adults and accounts for 1.5 million cases in the United States. IDDM patients do not produce insulin and must take daily insulin to stay alive. The critical shortage of donor organs coupled to the logistic demands of having an intact, acceptable pancreas available at a precise time and location, does not make this a feasible long-range solution. Based on the successful development and clinical use of a tissue engineered matrix for skin regeneration, Integra Lifesciences Corporation initiated studies to develop a novel approach to providing a tissue engineered pancreas for patients with IDDM. This development program will address the following objectives (1) the design and production of a sterile, RGD peptide-modified collagen matrix that will promote the adhesion, viability, and functionality of porcine islets, (2) the optimization of the culture conditions to maximize cell functionality prior to implantation, and (3) the use of a porcine model system to demonstrate the best implantation site. The purpose of this Phase I application is to establish the feasibility of producing a manufacturable, sterile product that will have a commercially viable impact on the survival and function of transplanted pancreatic islets. PROPOSED COMMERCIAL APPLICATIONS: On 1997, the annual direct and indirect costs of type I and II diabetes mellitus were estimated at 98.2 billion which represents about 10 percent of the total personal health care expenditure in the United States (1). More than 16 million Americans have diabetes and nearly 750,000 new cases are reported every year (2). Type 1 diabetes (insulin Dependent Diabetes Mellitus, IDDM) occurs most often in children and young adults and accounts for one-third of renal dialysis patients. IDDM patients do not produce insulin and must take daily insulin to stay alive. To date, however, insulin has not succeeded in eliminating the wide swings in blood glucose levels nor has it prevented the progression of serious complications of the disease.
