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Publications

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Neo-Kidney Augment Technology

Guthrie K.I., Rivera E., Sangha N., Bertram T.A., Jain D. and Basu J. (2014, November). Athymic Rat Reduced Kidney Mass Model: A Screening Tool to Identify Human-Sourced Cell-Based Therapeutic Prototypes for Regeneration and Stabilization of Kidney Function. Presented at American Society of Nephrology, Philadelphia, PA; November, 2014

Basu J., Ludlow J.W. (2014 September). Cell-based therapeutic products: potency assay development and application. Regen. Med. (2014) 9(4), 497-512.

Basu J., Sangha N., Bertram, T.A., Jain D. (2014, June). Dynamic Bio-distribution of Therapeutically Bioactive Selected Regenerative Renal Cells in Large Animal Pre-Clinical Model. Presented at the 12th Annual Meeting of the International Society for Stem Cell Research, Vancouver, CANADA, June 2014.

Knight T., Payne, R., Rivera E., Basu J., Robbins, N., McCoy D., Halberstadt, C., Jayo M. Jain D. (2013, November). Bioresponse of a Cell/Alginate Hydrogel Composite in Mammalian Kidney. Presented at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America, Atlanta Nov 10-13, 2013.

Helena Genberg, Torbjorn Lundgren, Andrew Bruce, Kelly Guthrie, Namrata Sangha, Joydeep Basu Elias Rivera, Thomas Spencer, Tim Bertram and Deepak Jain (2013, September). Attenuation of Disease Progression with Selected Renal Cell Populations in Animal Models of Chronic Kidney Disease.  Presented at: ISN Forefronts Symposia – Stem Cells and Kidney Regeneration Florence Italy Sep 12-15 2013

Jain, D., Payne, R., Halberstadt, C., Knight, T., Robbins, N., Rivera E., Kelley R., Ludlow, J., Guthrie, K., Bertram, T.A. (2012, November). Development of a Neo-Kidney Augment Product Intended to Prevent or Delay the Need for Dialysis or Transplantation in CKD Patients. Presented at the American Society of Nephrology Meeting, San Diego, CA Oct 30-Nov 4, 2012.

Jain D., Ludlow J.W.,  Halberstadt C.R., Payne R., Guthrie K., Genheimer C., Spencer T., Riveria E., Garg N., Bertram T.A. (2012, September). Regenerating Kidney Tissue with a Neo-Kidney Augment Implant Containing Selected Renal cells and Natural Biomaterial. Presented at the 3rd TERMIS World Congress 2012, Vienna, Austria, Sep 5-8, 2012.

Jain D., Payne R., Basu J., Halberstadt C.R., Knight T., Robbins, N. McCoy D., Riveria E., Genheimer C., Sangha N., Bruce A., Kelley, R., Bertram T.A. (2012, June). A Neo-Kidney Augment Product for Kidney Regeneration in a Large Animal Model of Chronic Kidney Disease. Presented at the 18th Annual International Society for Cellular Therapy (ISCT) Meeting, Seattle WA, June 5-8, 2012

Basu J., Ludlow J.W. (2012). Developmental Engineering the Kidney: Leveraging Principles of Morphogenesis for Renal Regeneration. Birth Defects Research (Part C) 96:30–38 (2012)

Genheimer, W.G., Ilagan R.M., Spencer T., Kelley R., Werdin E., Choudhury S., Jain D., Ludlow J.W., Basu J. (2012). Molecular Characterization of the Regenerative Response Induced by Intrarenal Transplantation of Selected Renal Cells in a Rodent Model of Chronic Kidney Disease. Cells Tissues Organs 2012;196:374–384

Spencer T., Kelley R., Werdin E., Bruce A., Jain D. (2011, December) Multivariate Analysis of Preclinical Data from the Tengion Neo-Kidney Augment.. Podium presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 11-14, 2010, Houston, Texas.

Jain D., Basu J., Halberstadt C., Rivera E., Knight T., Payne R., Robbins N., McCoy D., Guthrie K., Sangha N., Genheimer C., Ludlow J., and Bertram T. (2011, December) Selected Regenerative Renal Cells combined with Bioresorbable Natural Biomaterials catalyze in vivo Kidney Tissue Regeneration. Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 11-14, 2010, Houston, Texas.

Basu J., Payne R., Rivera E., Robbins N., McCoy D., Knight T., Sangha N., Guthrie K., Spencer T., Genheimer C., Jain D., Ludlow J.W. and Halberstadt C. (October 2011). Bio-Response of a Rodent Hemi-Nephrectomy Model to Implantation of Neo- Kidney Augment Prototypes Composed of Selected Renal Cells and Biomaterials. Poster presentation at Joint Congress 2011 Cell Transplant Society / International Xenotransplantation Association, October 23 – 26, Miami, Florida.

Kelley R., Spencer T., Werdin E., Bruce A., Ilagan R., Wallace S., Watts B., Choudhury S., Cox B., Guthrie K., Jayo M., Bertram T., Presnell S. (June 2011). Intra-renal Transplantation of Bioactive Renal Cells Preserves Renal Functions and Extends Survival in the ZSF1 model of Progressive Diabetic Nephropathy. Poster presentation at 71st Scientific Sessions of American Diabetes Association, June 24 – 27, 2011 in San Diego, CA.

Basu J., Genheimer C., Sangha N., Quinlan S., Guthrie K., Kelley R., Ilagan R., Jain D., Bertram T.A. and Ludlow J.W. (June 2011). Organ Specific Regenerative Markers in Peri-Organ Adipose: Kidney. Poster presentation to the 9th Annual meeting of International Society of Stem Cell Research (ISSCR), Toronto, Ontario Canada,June 15 – 18, 2011.

Jain D., Jayo M.J., Bertram T.A. (2011, May). Development of Tissue Engineered Regenerative Medicine Products using Selected Autologous Cells and Biomaterials. Presented at The International Society for Cellular Therapy 17th Annual Meeting, Rotterdam, The Netherlands, May 18-21, 2011

Bruce A., Watts B., Cox B., Genheimer C., Werdin E., Guthrie K., Ilagan R., Kelley R., Presnell S., Wallace S., Choudhury S. (2011, April). Hypoxic Exposure of Cultured Human Renal Cells Induces Mediators of Cell Migration and Attachment and Facilitates the Repair of Tubular Cell Monolayers in vitro. Podium presentation given at Experimental Biology Meeting in Washington, DC, April 10, 2011.

Jain D., Payne R. et al (2011, March). Catalyzing Kidney Regeneration using Selected Renal Cells and Biomaterials in a Neo-Kidney Augment Product. Oral Presentation given at Tissue Engineering meeting, Hilton Head, NC March 2011.

Basu J., Genheimer C.W., Rivera E.A., Payne R., Mihalko K., Guthrie K., Bruce A.T., Robbins N., McCoy D., Sangha N., Ilagan R., Knight T., Spencer T., Wagner B.J., Jayo M.J., Jain D., Ludlow J.W., Halberstadt C. (2011, March). Functional evaluation of primary renal cell/biomaterial Neo-Kidney Augment prototypes for renal tissue engineering Cell Transplant. 2011 Mar 24. doi: 10.3727/096368911X566172.

Payne R., Knight T., Basu J., Rivera E., Robbins N., McCoy D., Jayo M., Halberstadt C., Jain D. (2011, April). Bioresponse of Mammalian Kidney to Implantation of Polymeric Materials Poster presented at 2011 Society for Biomaterials Annual Meeting & Exposition, April 13-16, 2011 in Orlando, Florida.

Kelley R.W., Werdin E.S., Bruce A.T., Wallace S.M., Jayo M.J., Bertram T.A. and Presnell S.C. (2010, December). Bioactive Renal Cells Augment Renal Function in the ZSF1 model of Diabetic Nephropathy. Oral Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Choudhury S., Bruce A.T., Kelley R.W., Cox B.R., Werdin E.S., Watts B., Presnell S.C., and Ilagan R.M. (2010, December). Paracrine Factors Derived from Bioactive Kidney Cells Provide Anti-fibrotic Signals in vitro and may Mediate Regenerative Outcomes in vivo. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Ilagan R.M., Guthrie K.I., Cox B.R., Choudhury S., Bruce A.T., Watts B., O’Reilly D.D., Tang C., Genheimer C.W., Werdin E.S., Kelley R.W., and Presnell, S.C. (2010, December). Secreted Factors from Bioactive Kidney Cells Attenuate NF-kappa-B. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Basu J., Payne R., Rivera E., Robbins N., McCoy D., Knight T., Jayo M.J., Jain D., Halberstadt C.R. (2010, December). In vivo Evaluation of Biomaterials in Mammalian Kidney. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Basu J., Rivera E., Genheimer C.W., Robbins N., Payne R., McCoy D., Guthrie K.I., Sangha N., Knight T., Jayo M., Ludlow J.W., Jain D., and Halberstadt C.R.. (2010, December). Mammalian Kidney Nephrogenic Response to Primary Renal Cell/Biomaterial-based Neo-Kidney Augment™ Prototype. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Cell Transplant Approaches to Kidney Regeneration. (2010, October). Podium presentation at American Society of Transplantation-Annual Scientific Exchange (AST-ASE), Orlando, FL October 21-24, 2010.

Stem and Progenitor Marker Expression as a Predictor of Renal Regeneration in 5/6 Nephrectomized Rats Treated with Therapeutically Bio-Active Primary Renal Cell Sub-Populations. Poster presented at World Stem Cell Summit, held October 4-6, 2010 in Detroit, MI.

Presnell S.C., Jayo M.J., Jain D., & Bertram T.A. Discovery and Development of Regenerative Medicine Products Comprised of Autologous Cells and Biomaterials. Podium presentation at International Society for Cellular Therapy (ISCT) 2nd Annual Symposium on Stem Cell Translation, San Francisco, CA on September 27-28, 2010.

Presnell S.C., Bruce A.T., Wallace S.M., Choudhury S., Genheimer C., Cox B., Guthrie K.I., Werdin E.S., Tatsumi-Ficht P., Ilagan R., Kelley R.W., Rivera E.A., Ludlow J.W., Wagner B.J., Jayo M.J., Bertram T. (2010, September 16) Isolation, Characterization, and Expansion (ICE) Methods for Defined Primary Renal Cell Populations from Rodent, Canine, and Human Normal and Diseased Kidneys. Tissue Eng Part C Methods. 2010 Sep 16.

Kelley R., Werdin E.S., Bruce A.T., Choudhury S., Wallace S.M., Ilagan R.M., Cox B.R., Tatsumi-Ficht P., Rivera E.A., Spencer T., Rapoport H.S., Wagner B.J., Guthrie K., Jayo M.J., Bertram T.A., Presnell S.C. (2010, September 8). A tubular cell-enriched subpopulation of primary renal cells improves survival and augments kidney function in a rodent model of chronic kidney disease. Am J Physiol Renal Physiol (September 8, 2010). doi:10.1152/ajprenal.00221.2010

Kelley R., Werdin E.S., Bruce A.T., Choudhury S., Wallace S.M., Tatsumi-Ficht P., Rivera E.A., Spencer T., Rapoport H.S., Ilagan R.M., Wagner B.J., Jayo M.J., Bertram T.A., Presnell S.C. (2010, May 24). Bioactive Renal Cells Augment Kidney Function In A Rodent Model Of Chronic Kidney Disease.Podium Presentation at 16th Annual Meeting of The International Society For Cellular Therapy, Philadelphia, PA May 23-26, 2010.

Wallace S.M., Bruce A.T., Choudhury S., Tatsumi-Ficht P., Cox B.R., Wagner B.J., Kelley R., Presnell S.C. (2010, May 26). Quantitative Ex Vivo Characterization Of Human Renal Cell Population Dynamics Via High-Content Image-Based Analysis (HCA). Podium Presentation at 16th Annual Meeting of The International Society For Cellular Therapy, Philadelphia, PA May 23-26, 2010.

Kelley, R., Bruce, A., Wallace, S., Choudhury, S., Tatsumi, P., Das, A., Riveras, E., & Presnell, S. (2008, September 17-19). Enhanced renal cell function in dynamic 3D culture system. Poster presented at the KIDSTEM International Conference, Liverpool, England.

Ilagan RM, Guthrie K, Sangha N, Quinlan S, Delo O’Reilly D, Jain D, Bertram TA, Presnell SC, and Ludlow JW (2009, July 29-31).Characterization of primary adult canine renal cells (CRC) in a three-dimensional (3D) culture system permissive for ex vivo nephrogenesis.Poster presented at the 2009 KIDSTEM International Conference, Edinburgh, Scotland.

Kelley RW, Werdin ES, Bruce AT, Choudhury S, Wallace SM, Tatsumi-Ficht P, Rivera EA, Jayo MJ, Bertram TA, and Presnell SC (2009, July 29-31). Isolation and propagation of therapeutically-relevant cells, including Epo-producing cells, from severely diseased kidneys translates across rodents, large mammals and humans. Poster presented at the 2009 KIDSTEM International Conference, Edinburgh, Scotland.

Presnell S.C., Bruce A., Wallace S.M., Choudhury S., Kelley R., Tatsumi P., Werdin E., Rivera E., Merricks E., Nichols T.C., Jennette J.C., Jayo M.J., Bertram T.A. (2009, April 18). Isolation and characterization of bioresponsive renal cells from human and large mammal with chronic renal failure. Poster presented at the Experimental Biology Meeting, held in New Orleans, LA, April 18-22, 2009.

Tubular Organ Replacement

E. Rivera, T. Bivalacqua, M. Schoenberg, G. Steinberg, N. Smith, A. Robertson, J. Basu, A. Bruce, K. Guthrie, R. Payne,T. Spencer, D. Jain and T. Bertram. Clinical translation of a tissue engineered urinary diversion using a biodegradable scaffold seeded with adipose derived smooth muscle cells. Presented at the Stem Cell Trilogy, The Royal College of Pathology, London, UK. Jun5, 2013.

Ilagan R.M., Genheimer C.W., Quinlan S.F., Guthrie K.I., Sangha N., Ramachandrannair S., Kelley R.W., Presnell S.C., Basu J., Ludlow J.W. (October 2011). Smooth muscle phenotypic diversity is mediated through alterations in Myocardin gene splicing. J Cell Physiol. 2011 Oct;226(10):2702-11. doi: 10.1002/jcp.22622.

Jain D., Jayo M.J., Bertram T.A. (May 2011). Development of Tissue Engineered Regenerative Medicine Products Using Selected Autologous Cells and Biomaterials. Poster presentation to 17th Annual Meeting of International Society for Cellular Therapy (ISCT) in Rotterdam, The Netherlands, May 18 -21, 2011.

Basu J., Genheimer C.W., Guthrie K.I., Sangha N., Quinlan S.F., Bruce A.T., Reavis B., Halberstadt C., Ilagan R.M., Ludlow J.W. (2011 May 19).Expansion of the Human Adipose-Derived Stromal Vascular Cell Fraction Yields a Population of Smooth Muscle-Like Cells with Markedly Distinct Phenotypic and Functional Properties Relative to Mesenchymal Stem Cells. Tissue Eng Part C Methods. 2011 May 19. [Epub ahead of print].

Serban M.A., Knight T., Payne R., Basu J., Rivera E.A., Robbins N., McCoy D., Halberstadt C., Jain D., Bertram T.A. (2011, April). Fabrication of Chemically Crosslinked Gelatin Microspheres with Tunable Degradation Profiles Poster presented at 2011 Society for Biomaterials Annual Meeting & Exposition, April 13-16, 2011 in Orlando, Florida.

Presnell S.C., Jayo M.J., Jain D., & Bertram T.A. Discovery and Development of Regenerative Medicine Products Comprised of Autologous Cells and Biomaterials. Podium presentation at International Society for Cellular Therapy (ISCT) 2nd Annual Symposium on Stem Cell Translation, San Francisco, CA on September 27-28, 2010.

Basu J., Ludlow J.W. (2010, August 25). Platform technologies for tubular organ regeneration. Trends Biotechnol. 2010 Oct;28(10):526-33. Epub 2010 Aug 25.

Ludlow J.W., Basu J., Genheimer C., Guthrie K., Sangha N., Quinlan S., Bruce A.T., Ilagan R.M., Bertram T.A., Jain D. (2010, June 16). Phenotypic and Functional Distinction Between Mesenchymal Stem Cells and the Stromal Vascular Cell Fraction of Human Adipose Tissue. Poster presented at 8th Annual Meeting of the International Society for Stem Cell Research, held June 16-19, 2010 in San Francisco, California.

Bertram, T. A., & Jayo, M. J. (2008). Tissue engineered products: Preclinical development of neo-organs. In J. Cavagnero (Ed.), Preclinical safety evaluation of biopharmaceuticals: A science-based approach to facilitating clinical trials (pp. 799-826). New York: John Wiley & Sons.

Jayo, M. J., Watson, D. D., Wagner, B. J., & Bertram, T. A. (2008). Tissue engineering and regenerative medicine: role of toxicologic pathologists for an emerging medical technology. Toxicol Pathol, 36(1), 92-96.

Russell, A. J., & Bertram, T. A. (2007). Moving into the clinic. In R. Lanza, R. Langer & J. P. Vacanti (Eds.), Principles of tissue engineering (3rd ed., pp. 15-32). Burlington, MA: Elsevier Academic Press.

Basu J., Jayo M.J., Ilagan R.M., Guthrie K.I., Sangha N., Genheimer C.W., Quinlan S.F., Payne R., Knight T., Rivera E., Jain D., Bertram T.A., Ludlow J.W. (May 2012). Regeneration of Native-Like Neo-Urinary Tissue from Nonbladder Cell Sources. Tissue Engineering: Part A. 2012 May; 18(9-10):1025-34. 2012 Jan 16. [Epub ahead of print]

Justewicz D.M., Burnette T.B., Shokes J.E., Spencer T., Jain D. (2011, December) Genetic Stability of Autologous Human Smooth Muscle Cells.Oral Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 11-14, 2010, Houston, Texas.

Shokes J.E., Burnette T.B., McMahan J., Ramachandrannair S., Spencer T., Jain D. , Justewicz D.J. (2011, December) Characterization of Chemotherapy / Radiation Treated Human Smooth Muscle Cells for Use in Regenerative Medicine. Poster presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 11-14, 2010, Houston, Texas.

Shokes J.E., Burnette T.B, Shrestha S., Justewicz D.M., Spencer T., and Jain D. Characterization of Autologous Smooth Muscle Cells Following Treatment with Bladder Cancer Drugs. Oral Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Halberstadt C.R., Fish J., Robbins N., McCoy D., Campbell J., Boyd S., Payne R., Spencer T., Jain D. Development of a Bioreactor System for Preparation of Tubular Organs. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Jain D., Halberstadt C.R., Ludlow J.W., Payne R., Spencer T., Justewicz D., Jayo M.J., Wagner B.J., Bertram T.A. A Regenerative Urinary Diversion Tissue-Engineered from Autologous Smooth Muscle Cells and a Biodegradable Scaffold. Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Jayo M.J., Rivera E., Sharp W., Wagner B.J., Ludlow J.W., Jain D., Bertram T.A. Regeneration of Native-Like Mucocutaneous Region at the Skin-Conduit Junction Following Neo-Urinary Conduit™ Implantation.Poster Presentation given at Tissue Engineering and Regenerative Medicine International Society (TERMIS) – North America Annual Conference, December 5 – 8, 2010.

Genheimer C.W., Guthrie K.I., Shokes J.E., Bruce A.T., Quinlan S.F., Sangha N., Ilagan R.M., Basu J., Burnette T., Ludlow J.W. (2010, October 6). Increased Urothelial Cell Detection in the Primary Bladder Smooth Muscle Cell Cultures with Dual MACS/qRT-PCR Approach . Appl Immunohistochem Mol Morphol. 2010 Oct 6. [Epub ahead of print]

Jain D., Ludlow J.W., Guthrie K., Sangha N., Genheimer C., Shokes J., Burnette T., Justewicz D., Ilagan R., Wagner B.J., Bertram T.A., (2010, May 24). Smooth Muscle Cells Derived From Human Adipose Tissue For Use In Urologic Tissue Engineering. Podium Presentation at 16th Annual Meeting of The International Society For Cellular Therapy, Philadelphia, PA May 23-26, 2010.

Basu J, Guthrie K, Ilagan R, Sangha N, Genheimer C, Payne R, Rapoport S, Knight T, Wagner BJ, Jayo MJ, Jain D, Bertram TA, Ludlow JW (2009, July 8-11). Functional De Novo Neo-Urinary Conduit Formation From Porcine Peripheral Blood And Adipose Tissue Derived Smooth Muscle Cells. Poster presented at 2009 International Society for Stem Cell Research meeting, SPAIN.

Jain D., Ludlow J.W., Halberstadt C., Payne R., Wagner B.J., Jayo M.J., Bertram T.A. (2009, March 6). An Autologous Smooth Muscle Cell (Smc) Seeded Plga-Based Scaffold (Neo-Bladder Conduit) for Establishing an Incontinent Urinary Diversion. Poster presented at Regenerative Medicine: Advancing Next Generation Therapies meeting, March 5-8, 2009 at Hilton Head Island, SC.

Jain D., Ludlow J.W., Guthrie K., Johnson K., Bruce A., Bertram T. (2009, May 3). Skeletal Muscle Tissue As An Alternate Source Of Smooth Muscle Cells For Tissue-Engineered Neo-Urinary Implants. Poster presented at International Society for Cell Therapy (ISCT) 15th Annual Meeting, San Diego, CA, May 3-6, 2009.