John M. Centanni
Faculty > John M. Centanni
John M. Centanni
Researcher, Medicine: Quality Assurance & Regulatory Affairs Manager; Regulatory Affairs Support (Institute for Clinical and Translational Research [ICTR])
jmcetanni@medicine.wisc.edu
Organ System/Disease Focus
Federal regulation of drugs, devices, combination products, and biologics.
Aligned Research Focus
Tissue engineering, wound repair, stem cell therapy, cGMP manufacturing, and regenerative medicine.
Research Description
My current focus in the Department of Medicine, Division of Cardiovascular Medicine, as a regulatory affairs scientist, is to provide campus-wide support for the FDA approval process. Recent efforts include regulatory and scientific input on technology transfer, early clinical product development, and FDA communications as it relates to the design and execution of preclinical and clinical studies for NIH-NHLBI PACT projects. These efforts include evaluation of in vivo cell delivery methods, dosing regimen, safety, cell tracking, and distribution profiles. As translational and human clinical research projects continue to accelerate the demand for regulatory support escalates. I’ve provided regulatory support for Industry sponsored clinical studies developing cellular technologies from bench to bedside. Early phases of human clinical development of these technologies have proven successful in achieving the clinical endpoints prospectively defined by the clinical protocol. As a Cellular and Molecular Biologist, I have maintained a PI status on a number of NIH sponsored SBIR/STTR Fast-Track grant awards. One area of research focused on development of new therapies to enhance wound healing and expedite wound closure of acute or chronic skin wounds. Our approach was to provide wound healing factors directly to the wound bed to elicit antimicrobial properties, inhibit infection, and stimulate wound closure. Early in my research career, I generated animal models of disease using state-of-the-art genetic engineering techniques such as pronuclear microinjection and homologous recombination. I created several novel transgenic animal lines in a variety of animal species. My thesis and defense research included the isolation and genetic manipulation of embryonic stem cells used to generate animal disease models.
Selected References
Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. (2009) Phase I/II clinical evaluation of StrataGraft®: a consistent, pathogen-free human skin substitute. J Trauma. 66(3):866-873; discussion 873-874.
Thomas-Virnig CL, Centanni JM, Johnston CE, He LK, Schlosser SJ, Van Winkle KF, Chen R, Gibson AL, Szilagyi A, Li L, Shankar R, Allen-Hoffmann BL. (2009) Inhibition of multidrug-resistant Acinetobacter baumannii by nonviral expression of hCAP-18 in a bioengineered human skin tissue. Mol. Ther. 17(3):562-569.
Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. (2011). StrataGraft® skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: Results from a prospective, randomized, controlled dose escalation trial. Ann. Surg. 253(4):637-643.