VitaCyte Featured as an NIH Seed Success Story

The recent NIH Seed Success Story, “From Indiana to Impact: How NIH SBIR helped VitaCyte Power Cell Breakthroughs,” summarizes the key contributions VitaCyte made to improve the use of Clostridial histolyticum collagenase and neutral proteases for isolating mammalian cells from tissue. VitaCyte was fortunate to receive a 2-year, $500,000 Phase I Small Business Innovation Research (SBIR) award in July 2004 for “Tissue dissociation enzymes for islets and other cells.” This funding, coupled with supplemental SBIR matching awards from the State of Indiana, was critical for VitaCyte to supply purified collagenase and protease enzymes to isolate human islets used in the Clinical Islet Transplantation Consortium clinical trial.

VitaCyte’s receipt of a Phase II SBIR award in May 2009 enabled the scale-up to manufacture of the three forms of recombinant C. histolyticum collagenase: intact class I (rC1_{116 kDa}), intact class II (rC2_{114 kDa}), and truncated class I (rC1_{100 kDa}). This award enabled VitaCyte to fund a recombinant collagenase dose study performed in collaboration with Bernhard Hering’s lab at the University of Minnesota. The study focused on determining how doses of collagen-degrading activity (rC1_{116 kDa}) and Wunsch activity (rC2_{114 kDa}) affected human islet yield and function when a fixed dose of BP Protease (a Dispase-equivalent enzyme) was used in these isolations. The results from 12 human islet isolations assessing the effectiveness of four different collagenase compositions showed that varying the rC1 and rC2 enzyme compositions had no impact on islet yield or function. The design and results from these studies were published in Transplantation Direct and were recently reviewed by Mike Green in a webinar entitled “Is there an optimal enzyme dose for human islet isolation?”

VitaCyte’s receipt of the Phase I and Phase II NIDDK SBIR awards was invaluable in setting a high standard of excellence for the purification and characterization of natural and recombinant Clostridial histolyticum collagenase. This standard led the firm to use this approach to make additional contributions to improve collagenase-mediated cell isolation. A complete list of VitaCyte’s scientific contributions can be found on VitaCyte’s website.