Miller School of Medicine >> UM Innovation >> Technology Transfer >> For Industry
 
ID# UMG-01
Method for Assessing Beta-Cell Viability in Human Pancreatic Islets for Transplantation and Research
Hirohito Ichii and Camillo Ricordi
 
Problem
The viability and purity of beta-cell preparations from human pancreatic islets is critical for successful transplantation in patients with Type 1 diabetes, and for future research efforts.  Beta-cells are important in that they produce insulin.  Currently, viability and purity of these cells is determined by DNA-binding dye exclusion, dithizone (DTZ) staining, and in vitro glucose-stimulated insulin release.  These methods however, have a number of drawbacks, chiefly, the inability to distinguish between islet preparations that will fail to reverse diabetes vs. those that result in excellent function.
 
Solution
The inventors have developed a novel method to rapidly and precisely quantify the mass and viability of beta-cells in human islets by using Laser Scanning Cytometry and cytofluorimetry.  A major advantage is that in a short time, a substantially higher number  (≥ 30,000) of cells can be assessed objectively, compared to the few hundred cells that are counted manually or by operator-assisted imaging analysis using the current methodologies.  The method allows evaluation of viable beta-cells without interference of other cells in the preparation. 
 
Competitive Advantage
 A substantially higher number (≥ 30,000) of cells can be assessed objectively in a short time, compared to the few hundred cells that are counted manually or by operator-assisted imaging analysis using the current methodologies.  In addition, this method is able to identify islet preparations that will result in excellent function vs. those that will fail to reverse diabetes.
 
Applications
The method can be modified and simplified to be an assay kit, similar to the commercially available intra-cytokine or apoptosis assay kit.  The technique could be applied to other cell types (e.g., ductal cells, pancreatic progenitor cells) in human preparations, and automated for quality control screening of cell products to be used for clinical or research applications.  Finally, in addition to human cell analysis, the technique could be applied for the assessment of animal cell products, such as monkey, rodent, canine and porcine islet preparations.
 
Patent Status
 International Patent Appln No. PCT/US2007/070772 entitled “A NOVEL METHOD FOR THE ASSESSMENT OF CELLULAR COMPOSITION AND BETA-CELL VIABILITY IN HUMAN ISLET PREPARATIONS” was filed on June 8, 2007.
 
Licensing Opportunity
We are seeking collaborative research and licensing options for a cell viability assay kit.
 
About the Inventors
Dr. Hirohito Ichii, M.D., Ph.D. is a Research Assistant Professor of Surgery in the Diabetic Research Institute.  Dr. Camillo Ricordi, M.D., serves as Professor of Surgery, Medicine, Biomedical Engineering, Microbiology and Immunology.  He is also Chief of the Division of Cellular Transplantation, Department of Surgery and the Scientific Director and
Chief Academic Officer of the Diabetes Research Institute.
 
Selected References
 Ichii H, Inverardi L, Pileggi A, Molano RD, Cabrera O, Caicedo A, Messinger S, Kuroda Y, Berggren PO, Ricordi C. A novel method for the assessment of cellular composition and beta-cell viability in human islet preparations. Am J Transplantation.2005 Jul;5(7):1635-45.
 
 

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