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Clinical Work

Our work in Pittsburgh on skin therapy development is annotated in the following paper citations:

  1. Etiologies for clinical studies in the area were clinically evaluated and case reports described:
    Esteban-Vives R, Choi MS, Young M, Over P, Ziembicki J, Corcos A, Gerlach JC. Second-degree burn injuries with six etiologies treated with autologous noncultured cell-spray grafting. Burns. 2016. (in Press)
  2. An in vitro assay to evaluate biomaterials for innovative wound healing was developed:
    Esteban-Vives R, Young MT, Ziembicki J, Corcos A, Gerlach JC. Effects of wound dressings on cultured primary keratinocytes. Burns. 2016 Feb;42(1):81-90. doi: 10.1016/j.burns.2015.06.016. Epub 2015 Dec 9. PMID: 26678326
  3. Innovative wound dressings in development were tested:
    Plettig J, Johnen CM, Bräutigam K, Knöspel F, Wönne EC, Schubert F, Plöger F, Unger JK, Reutzel-Selke A, Bornemann R, Zeilinger K, Gerlach JC. Feasibility study of an active wound dressing based on hollow fiber membranes in a porcine wound model. Burns. 2015. Jun;41(4):778-88. doi: 10.1016/j.burns.2014.09.022. Epub 2014 Oct 18. PMID: 25451146
  4. The cell-biomaterial compatibility was tested for the development of innovative wound dressings:
    Schmelzer E, Over P, Gridelli B, Gerlach JC (2016). Response of Primary Human Bone Marrow Mesenchymal Stromal Cells and Dermal Keratinocytes to Thermal Printer Materials in vitro. J Med Biol Eng. 2016;36:153-167. DOI:10.1007/s40846-016-0118-z Epub 2016 Mar 30 PMCID: PMC4853461 PMID: 27231463
  5. Effects on the differentiation of primary epidermal stem cells in culture were described:
    Esteban-Vives R, Young M, Over P, Schmelzer E, Corcos A, Ziembicki J, Gerlach J. In vitro keratinocyte expansion for cell transplantation therapy is associated with differentiation and loss of basal layer derived progenitor population. Differentiation. 2015 pii: S0301-4681(15)00042-0. doi: 10.1016/j.diff.2015.05.002. [Epub ahead of print]
  6. Fetal tissue derived cells for cell banking of a homologous cell source were characterized:
    Johnen C, Chinnici C, Triolo F, Plettig J, Bräutigam K, Amico G, Young M, Over P, Esteban-Vives R, Turner M, Thompson R, Schmelzer E, Zeilinger K, Rubin P, Vizzini G, Conaldi PG, Gridelli B, Gerlach JC. Phenotypical characterization of 6-21 week gestational age human dermis and epidermal cell isolation methods for in vitro studies on epidermal progenitors. Burns. 2013 Mar; 39(2):300-10 doi: 10.1016/j.burns.2012.05.025. Epub 2012 Jun 30. PMID: 22749444.
  7. Development of autologous cell procurement methods and clinical evaluations:
    Gerlach JC, Johnen C, Ottoman C, Bräutigam K, Plettig J, Belfekroun C, Münch S, Hartmann B. Method for autologous single skin cell isolation for regenerative cell spray transplantation with non-cultured cells. Int J Art Org. 2011;34(3):271-279. PMID: 21480179
    and
    Gerlach JC, Johnen C, McCoy E, Bräutigam K, Plettig J, Corcos A. Autologous skin cell spray-transplantation for a deep dermal burn patient in an ambulant treatment room setting. Burns. 2011 Jun;37(4):e19-23. doi: 10.1016/j.burns.2011.01.022 Epub 2011 Feb 19. PMID: 21334816
    and
    Hartmann B, Ekkernkamp A, Johnen C, Gerlach JC, Belfekroun C, Küntscher MV. Sprayed cultured epithelial autografts for deep dermal burns of the face and neck. Ann Plast Surg. 2007 Jan; 58(1): 70-3. PMID: 17197946
  8. Patient preconditions as potential limitations for clinical cell isolation were studied on patient samples:
    Johnen C, Hartmann B, Steffen I, Bräutigam K, Toman N , Küntscher MV, Gerlach JC. Skin cell isolation and expansion for cell transplantation is limited in patients using tobacco, alcohol, or are exhibiting diabetes mellitus. Burns 2006 Mar;32(2):194-200. Epub 2006 Jan 31. PMID: 16448759
  9. An active wound dressing was developed:
    Plettig J, Johnen C, Bräutigam K, Zeilinger K, Bornemann R, Gerlach JC. Active wound dressing with artificial capillaries for temporary wound irrigation and skin cell supply. Artif Organs. 2011 Apr;36(4):446-9. doi: 10.1111/j.1525-1594.2011.01363.x. Epub 2011 Nov 11. PMID: 22074237
  10. Biomaterials for active wound dressings were investigated:
    Johnen C, Steffen I, Beichelt D, Bräutigam K, Witascheck T, Toman N, Moser V, Ottomann C, Hartmann B, Gerlach JC. Culture of subconfluent human fibroblasts and keratinocytes using biodegradable transfer membranes. Burns. 2008 Aug;34(5):655-63. PMID: 18226463
  11. The provision of regenerative factors by active wound dressings was studied in pig experiments:
    Plettig J, Johnen CM, Bräutigam K, Knöspel F, Wönne EC, Schubert F, Plöger F, Unger JK, Reutzel-Selke A, Bornemann R, Zeilinger K, Gerlach JC. Feasibility study of an active wound dressing based on hollow fiber membranes in a porcine wound model. Burns. 2015. Jun;41(4):778-88. doi: 10.1016/j.burns.2014.09.022. Epub 2014 Oct 18. PMID: 25451146
  12. Adult stem cells of the skin were characterized:
    Schlabe J, Johnen C, Schwartlander R, Moser V, Hartmann B, Gerlach JC, Küntscher MV. Isolation and culture of different epidermal and dermal cell types from human scalp suitable for the development of a therapeutic cell spray. Burns. 2008 May;34(3):376-84. Epub 2007 Sep 14 PMID: 17869000

Another topic is technology development for liver progenitor cell transplantations:

  1. Iwase H, Liu H, Schmelzer E, Ezzelarab M, Wijkstrom M, Hara H, Lee W, Singh J, Long C, Lagasse E, Gerlach JC, Cooper DKC, Gridelli B. 2017. Transplantation of hepatocytes from genetically engineered pigs into baboons. Xenotransplantation. 2017 Mar;24(2). Doi: 10.1111/xen. 12289. Epub 2017 Jan 28. PMID: 28130881 PMC5397320
  2. Zhou H, Liu H, Ezzelarab M, Schmelzer E, Wang Y, Gerlach J, Gridelli B, Cooper DK (2015). Experimental hepatocyte xenotransplantation-a comprehensive review of the literature. Xenotransplantation. 2015 May 7. doi: 10.1111/xen.12170.  PMID: 25950141
  3. Pietrosi G, Vizzini G, Gerlach JC, Chinnici C, Luca A, Amico G, D’Amato M, Conaldi PG, Petri SL, Spada M, Tuzzolino F, Alio L, Schmelzer E, Gridelli B.  Phase I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease. Cell Transplant. 2014; Jun 26; doi: 10.3727/096368914X682422 [Epub ahead of print] PMID: 24971879
  4. Gridelli B, Vizzini G, Pietrosi G, Luca A, Spada M, Gruttadauria S, Cintorino D, Amico G, Chinnici C, Miki T, Schmelzer E, Conaldi P, Triolo F, Gerlach JC. Efficient human fetal liver cell isolation protocol based on vascular perfusion for liver cell based therapy and a case report on cell transplantation. Liver Transplant. 2012, 18:226-37. PMID: 22034152
  5. Darnell M, Schreiter T, Zeilinger K, Urbaniak T, Soderdahl T, Rossberg I, Dillner B, Berg AL, Gerlach JC, Andersson TB. Cytochrome P450 (CYP) dependent metabolism in HepaRG cells cultured in a dynamic three-dimensional (3D) bioreactor. Drug Metab Dispos. 2011 dmd.110.037721; published ahead of print; doi:10.1124/dmd.110.037721. PMID: 21436404
  6. Balmert C, Daniel McKeel D, Triolo F, Gridelli B, Zeilinger K, Bornemann R, Gerlach JC. Perfusion circuit concepts for hollow-fiber bioreactors used as in vitro cell production systems or ex vivo bioartificial organs. Int J Artif Organs. 2011 May;34(5):410-21. PMID: 21623585
  7. Mandenius CF, Andersson TB, Alves PM, Batzl-Hartmann C, Björquist P, Carrondo MJ, Chesne C, Coecke S, Edsbagge J, Fredriksson JM, Gerlach JC, Heinzle E, Ingelman-Sundberg M, Johansson I, Küppers-Munther B, Müller-Vieira U, Noor F, Zeilinger K. Toward preclinical predictive drug testing for metabolism and hepatotoxicity by using in vitro models derived from human embryonic stem cells and human cell lines - a report on the Vitrocellomics EU-project. Altern Lab Anim.2011 May;39(2):147-71. PMID: 21639679
  8. Pietrosi G, Vizzini G, Luca A, Soada M, Conaldi PG, Triolo F, Gerlach JC, Gridelli B. Is human fetal liver stem cell transplantation a pancea for alcohol-induced liver decompensation? Cell Transplant (letter), in press. PMID: 21396166
  9. Lopez F, Bartolo CD, Piazza T, Passannanti A, Gerlach JC, Gridelli B, Triolo F. A Quality Risk Management Model Approach for Cell Therapy Manufacturing. Risk Anal. 2010;30(12):1857-7 PMID: 20723148
  10. Lübberstedt M, Müller-Vieira U, Mayer M, Biemel KM, Knöspel F, Knobeloch D, Nüssler AK, Gerlach JC, Zeilinger K. HepaRG human hepatic cell line utility as a surrogate for primary human hepatocytes in drug metabolism assessment in vitro. J Pharmacol Toxicol Methods. 2011 Jan-Feb;63(1):59-68. Epub 2010 May 9. PMID: 20460162.
  11. Vodovotz Y, Constantine G, Faeder J, Mi Q, Rubin J, Barelts J, Sarkar J, Equires R, Okonkwo D, Gerlach JC, Zamora R, Luckhart S, Ermentrout B, An G. Translational Systems Approaches to the Biology of Inflammation and Healing. Immunopharmacology and Immunotoxicology. 2010;32(2):181–195. DOI: 10.3109/08923970903369867. PMID: 20170421
  12. Gerlach JC, Brayfield C, Puhl G, Bornemann R, Müller C, Schmelzer E, Zeilinger K. Lidocaine/Monoethylglycineexylidide test, galactose limination test, and sorbitol test for metabolic assessment of liver cell bioreactors. Artificial Organs. 2010 Jun;34(6):462-72. PMID: 20456323
  13. Prince JM, Vodovotz Y, Baun M, Monga S, Billiar TR, Gerlach JC. The Nitric Oxide Donor S-nitrosoglutathione (GSNO) Reduces Apoptotic Primary Liver Cell Loss in a 3D Perfusion Bioreactor Culture Model Developed for Liver Support. Tissue Engineering. 2010;16(3):861-6. PMID: 19814591
  14. Schmelzer E, Mutig K, Schrade P, Bachmann S, Gerlach JC, Zeilinger K. Effect of human patient plasma ex vivo treatment on gene expression and progenitor cell activation of primary human liver cells in multi-compartment 3D perfusion bioreactors for extracorporeal liver support.  Biotech Bioengineering. 2009;103(4):817-27. PMID: 19274748
  15. Marceno R, Triolo F, Cappuzzo V, Amico G, Gridelli B, Vizzini G, Gerlach JC, Miki T, Chinnici C, Ingrassia F, Galvagno D, Bavetta R, Carcassi C, Macchiarella A, Mistretta S, Merlo D, Tortorici G. Immunological advantages of human fetal hepatocytes for the treatment of liver disease? Tissue Antigens. 2008;71(4):306-307.
  16. Dong J, Mandenius CF, Lübberstedt M, Nüssler AK, Gerlach JC, Zeilinger K. Evaluation and optimization of hepatocyte culture media factors by Design of Experiments (DoE) methodology. Cytotechnology. 2008;57(3):251-61. PMID: 19003182; PMC: 2570004
  17. Gerlach JC, Zeilinger K, Patzer II JF: Bioartificial liver systems: why, what, whither? Regenerative Medicine. 2008;3:575-595. PMID: 18588477
  18. Pless G, Steffen I, Zeilinger K, Sauer IM, Katenz E, Kehr DC, Roth S, Mieder T, Schwartlander R, Müller C, Wegner B, Hout MS and Gerlach JC. Evaluation of Primary Human Liver Cells in Bioreactor Cultures for Extracorporeal Liver Support on the Basis of Urea Production. Artificial Organs. 2006;9:686-694. PMID: 16934097
  19. Guthke R, Zeilinger K, Sickinger S, Schmidt-Heck W, Buentemeyer H, Iding K, Lehmann J, Pfaff M, Gerlach JC.  Dynamics of amino acid metabolism of primary human liver cells in 3D bioreactors.  Bioprocess Biosyst Eng. 2006, Apr:331-340. PMID 16550345; PMC: 1705492
  20. Pfaff M, Toepfer S, Zeilinger K, Roth S, Driesch D, Woetzel D, Schmidt-Heck W, Guthke R, Witaschek T, Gerlach JC.  Systems Analysis of the Dynamic Input/Output Behavior of a Multi-Compartment Capillary Membrane Bioreactor for High-Density Liver Cell Culture.  Biomedizinische Technik. 2005 (50): 1617-1618
  21. Zeilinger K, Roth S, Witaschek T, Pfaff M, Toepfer S, Driesch D, Schmidt-Heck W, Guthke R, Gerlach JC.  Kinetic Analysis of the Electrolyte distribution in a Perfusion 3D-Bioreactor for High-Density Liver Cell Culture.  Biomedizinische Technik. 2005 (50):951-952
  22. Sauer IM, Schwartlander R, Van der Jagt O, Steffen I, Efimova E, Pless G, Kehr DC, Kardassis D, Frühauf JH, Gerlach JC, Neuhaus P. In vitro evaluation of the transportability of viable primary human liver cells originating from discarded donor organs in bioreactors. Artif Organs. 2005 Feb;29(2):144-51. PMID: 15670283
  23. Zeilinger K, Holland G, Sauer IM, Efimova E, Kardassis D, Obermayer N, Liu M, Neuhaus P, Gerlach JC. Time course of primary liver cell reorganization in three-dimensional high-density bioreactors for extracorporeal liver support: an immunohistochemical and ultrastructural study. Tissue Engineering. 2004, 10(7): 1113-1124 (2). PMID: 15363168
  24. Sauer IM, Goetz M, Steffen I, Walter G, Kehr DC, Schwartlander R, Hwang YJ, Pascher A, Gerlach JC, Neuhaus P. In Vitro Comparison of the Molecular Absorbent Recirculation system (MARS) and Single-pass Albumin Dialysis (SPAD). Hepatology. 2004, 39(5): 1408-1414. PMID: 15122770
  25. Sauer IM, Zeilinger K, Pless G, Kardassis D, Theruvath T, Pascher A, Goetz M, Neuhaus P, Gerlach JC. Extracorporeal liver support based on primary human liver cells and albumin dialysis-- treatment of a patient with primary graft non-function.  J Hepatology. 2003, Oct;39(4): 649-653. PMID: 12971979
  26. Irgang M, Sauer IM, Karlas A, Zeilinger K, Gerlach JC, Kurth R, Neuhaus P, Denner J. Porcine endogenous retroviruses: no infection in patients treated with a bioreactor based on porcine liver cells. Clinical Virology 2003, J Clin Virol. 2003, 28(2): 141-154. PMID: 12957184
  27. Gerlach JC, Mutig K, Zeilinger K, Sauer IM, Mieder T, Naumann G, Grunwald A, Pless G, Schrade P, Efimova E, Goetz M, Mas A, Vienken J, Bachmann S, Neuhaus P. The use of primary human liver cells originating from discarded grafts in a bioreactor for liver support therapy and the prospects of culturing adult liver stem cells in bioreactors: a morphological study. Transplantation. 2003, 76(5):781-786. PMID: 14501853
  28. Sauer IM, Kardassis D, Zeilinger K, Pascher A, Gruenwald A, Pless G, Irgang M, Kraemer M, Puhl G, Frank J, Müller AR, Steinmüller T, Denner J, Neuhaus P, Gerlach JC. Clinical extracorporeal hybrid liver support--phase I study with primary porcine liver cells. Xenotransplantation. 2003, 10: 460-469. PMID: 12950989
  29. Gerlach JC, Zeilinger K, Grebe A, Puhl G, Pless G, Sauer I, Grünwald A, Schnoy, Müller C, Neuhaus P. Recovery of Preservation Injury Primary Human Hepatocytes and Nonparenchymal Cells to Tissue-Like Structures in Large-Scale Bioreactors for Liver Support: An Initial Transmission Electron Microscopy Study. Journal of Investigative Surgery. 2003; Mar-Apr;16(2):83-92. PMID: 12746191
  30. Gerlach JC, Zeilinger K, Sauer IM, Mieder T, Nauman G, Grünwald A, Pless G, Holland A, Mas A, Vienken J, Neuhaus P. Extracorporeal liver support: Porcine or human cell based systems? Int J Artif Org. 2002; 25 (10): 1013-1018. PMID: 12456044
  31. Sauer IM, Zeilinger K, Obermayer N, Pless G, Pascher A, Mieder T, Roth S, Goetz M, Kardassis D, Mas A, Neuhaus P, Gerlach JC. Primary human liver cells as source for modular extracorporeal liver support--a preliminary report. Int J Art Org. 2002; 25 (10): 1001-1006. PMID: 12456042
  32. Sauer I, Gerlach JC. Modular Extracorporeal Liver Support (MELS). Art Org. 2002; 26(8):703-706. PMID: 12139497

Another focus is in the area of stem cell research; here we published some exiting paper:

  1. Knöspel F, Freyer N, Stecklum M, Gerlach JC, Zeilinger K. Periodic harvesting of embryonic stem cell from a hollow-fiber membrane based four-compartment bioreactor. Biotechnol Prog. 2016 Jan-Feb;32(1): 141-51. doi: 10.1002/btpr.2182 Epub 2015 Nov 3 PMID: 26486457
  2. Esteban-Vives R, Young M, Over P, Schmelzer E, Corcos A, Ziembicki J, Gerlach J. In vitro keratinocyte expansion for cell transplantation therapy is associated with differentiation and loss of basal layer derived progenitor population. Differentiation. 2015 Jun 30. pii: S0301-4681(15)00042-0. doi: 10.1016/j.diff.2015.05.002. [Epub ahead of print] PMID: 26142155
  3. Minteer DM, Young MT, Lin YC, Over PJ, Rubin JP, Gerlach JC, Marra KG. Analysis of type II diabetes mellitus adipose-derived stem cells for tissue engineering applications. J Tissue Eng. 2015 Apr 2;6:2041731415579215. doi: 10.1177/2041731415579215. eCollection 2015. PubMed PMID: 26090087; PubMed Central PMCID: PMC4456321
  4. Housler GJ, Pekor C, Miki T, Schmelzer E, Zeilinger K, Gerlach JC. 3-D Perfusion Bioreactor Process Optimization for CD34+ Hematopoietic Stem Cell Culture and Differentiation towards Red Blood Cell Lineage. Journal of Bone Marrow Research. 2014 October 10; 1(150)
  5. Pekor C, Gerlach JC, Nettleship I, Schmelzer E. Induction of Hepatic and Endothelial Differentiation by Perfusion in a Three-Dimensional Cell Culture model of Human Fetal Liver. Tissue Eng Part C Methods. 2015 Feb 11 [Epub ahead of print] PMID: 25559936
  6. Schmelzer E, Finoli A, Nettleship I, Gerlach JC. Long-term Three-dimensional Perfusion Culture of Human Adult Bone Marrow Mononuclear Cells in Bioreactors. Biotechnol Bioeng. 2014 Oct 21. doi: 10.1002/bit.25485. [Epub ahead of print] PMID: 25335987
  7. Gerlach JC, Over P, Foka HG, Turner ME, Thompson RL, Gridelli B, Schmelzer E. Role of transcription factor CCAAT/enhancer-binding protein alpha in human fetal liver cell types in vitro. Hepatol Res. 2014 Sep 5. doi: 10.1111/hepr.12420. [Epub ahead of print] PubMed PMID: 25195540
  8. Keil M, Siegert A, Eckert K, Gerlach JC, Haider W, Fichtner I. Transcriptional expression profile of cultured human embryonic stem cells in vitro and in vivo. In Vitro Cell.Dev.Biol. 2012; Feb;48:165-174. PMID: 22311374
  9. Gerlach JC, Over P, Turner ME, Thompson RL, Foka HG, Chen WC, Peault B, Gridelli B, Schmelzer E. Perivascular Mesenchymal Progenitors in Human Fetal and Adult Liver. Stem Cells Dev. 2012 Aug 30. [Epub ahead of print] PMID: 22931482
  10. Miki T, Ring A, Gerlach JC. Hepatic differentiation of human embryonic stem cell is promoted three-Dimensional Dynamic Perfusion Culture Conditions Promote Hepatic Differentiation of Human Embryonic stem Cells. Tissue Eng Part C Methods. 2011 May;17(5):557-68. PMID: 21210720
  11. Stachelscheid H, Wulf-Goldenberg A, Eckert K, Jensen J, Edsbagge J, Bjorquist P, Rivero M, Strehl R, Jozefczuk J, Prigione A, Adjaye J, Urbaniak T, Bussmann P, Zeilinger K, Gerlach JC. Teratoma formation of human embryonic stem cells in three-dimensional perfusion culture bioreactors. J Tissue Eng Regen Med. 2012 Mar 12 doi: 10.1002/term.1467. PMID: 22438087
  12. Gerlach JC, Lin Y-C, Brayfield CA, Minteer D, Li H, Rubin JP, Marra KG. Adipogenesis of Human Adipose-Derived Stem Cells within 3D Hollow Fiber-Based Bioreactors. Tissue Engineering, Part C. 2012; 18(1): 54-61. PMID: 21902468
  13. Housler J, Miki T, Schmelzer E, Pekor C, Zhang X, Kang L, Voskinarian-Berse V, Abbot S, Zeilinger K, Gerlach JC. Compartmental Hollow Fiber Capillary Membrane Based Bioreactor Technology for in vitro Studies on Red Blood Cell Lineage Direction of Hematopoietic Stem Cells. Tissue Engineering Part C: Methods. February 2012, 18(2): 133-142. PMID: 21933020
  14. Knöspel F, Schindler RK, Lübberstedt M, Petzolt S, Gerlach JC, Zeilinger K. Optimization of serum-free culture medium for mouse embryonic stem cells using design of experiments (DoE) methodology. Cytotechnology. 2010;62(6):557-71. PMID: 20859764
  15. Gerlach JC, Witaschek T, Strobel C, Brayfield CA, Bornemann R, Zeilinger K. Feasibility of using sodium chloride as a tracer for the characterization of the distribution of matter in complex multi-compartment 3D bioreactors for stem cell culture. Int J Artif Organs. 2010 June;33(6):399-404. PMID: 20669145
  16. Schmelzer E, Triolo F, Turner ME, Thompson RL, Zeilinger K, Reid LM, Gridelli B, Gerlach JC. Three-dimensional perfusion bioreactor culture supports differentiation of human fetal liver cells. Tissue Eng Part A. 2010 June;16(6):2007-16. PMID: 20088704
  17. Ring A, Gerlach JC, Peters G, Pazin B, Minervini C, Turner M, Thompson R, Triolo F, Gridelli B, Miki T. Hepatic maturation of human fetal hepatocytes in four-compartment 3D perfusion culture. Tissue Eng Part C Methods. 2010 Oct;16(5):835-45. PMID: 19883207
  18. Gerlach JC, Lübberstedt M, Edsbagge J, Ring A, Hout M, Baun M, Rossberg I, Knöspel F, Bussmann P, Miki T, Peters G, Eckert K, Wulf-Goldenberg A, Björquist P, Stachelscheid H, Urbaniak T, Zeilinger K. Interwoven four-compartment capillary membrane technology for 3D perfusion with decentral mass exchange to scale-up embryonic stem cell culture. Cells Tissues Organs. 2010 June;192(1):39-49. Doi: 10.1159/000000000. PMID: 20197653
  19. Wohler I, Stachelscheid H, Borstlap J, Zeilinger K, Gerlach JC. The Characterization Tool: A knowledge-based stem cell, differentiated cell, and tissue database with a web-based analysis front-end. Stem Cell Res. 2009;3(2-3):88-95. PMID: 19520631
  20. Gerlach JC, Hout M, Edsbagge J, Björquist P Lübberstedt M, Miki T, Stachelscheid H, Schmelzer E, Schatten G, Zeilinger K.  Dynamic 3D culture promotes spontaneous embryonic stem cell differentiation in vitro.  Tissue Engineering Part C Methods. 2010 Feb 16;(1):115-21. PMID: 19382830; PMC: 2819805
  21. Lin YC, Brayfield CA, Gerlach JC, Rubin JP, Marra KG. Peptide modification of polyethersulfone surfaces to improve adipose-derived stem cell adhesion. Acta Biomaterialia. 2009; 5(5):1416-1424.; doi:10.1016/j.actbio.2009.01.025. PMID: 19129013
  22. Stachelscheid H, Urbaniak T, Ring A, Spengler B, Gerlach JC, Zeilinger K. Isolation and Characterization of Adult Human Liver Progenitors from Ischemic Liver Tissue Derived from Therapeutic Hepatectomies. Tissue Eng Part A. 2009 Jul;15(7):1633-43. PMID: 19108677
  23. Izumi M, Pazin BJ, Minervini CF, Gerlach JC, Ross MA, Stolz DB, Turner ME, Thompson RL, Miki T.  Quantitative comparison of stem cell marker-positive cells in fetal and term human amnion.  Journal of Reproductive Immunology. 2009;81:39-43. doi:10.1016/j.jri.2009.02.007. PMID: 19501410
  24. Borstlap J, Kurtz A, Stacey G, Elstner A, Damaschun A, Arán B, Gerlach JC, Izpisúa JC, Veiga A. Development of a European Human Embryonic Stem Cell Registry. Regen. Med. (2008);3(6): 945-51. PMID: 18947315
  25. Monga P, Gerlach JC. Human fetal hepatocyte behavior in 3D perfusion culture bioreactors.  Journal of Organ Dysfunction. 2007;3(3):183-192. DOI: 10.1080/17471060601180779
  26. Monga, PS, Hout MS, Baun MJ, Micsenyi A, Muller P, Tummalapalli L, Ranade AR, Strom SC, Gerlach JC.  Mouse Fetal Liver Cells in Artificial Capillary Beds in Three-Dimensional Four-Compartment Bioreactors. Am J Pathol. 2005;167:1279-1292. PMC: 1603778. PMID: 16251412

The bioreactors developed by our group were first introduced into a clinical setting in a phase I study utilizing primary porcine cells. Eight patients with acute liver failure, coma stage II-IV, were treated to bridge the waiting time for an organ transplant while listed at Eurotransplant as high-urgency cases. The condition of all patients stabilized during the course of treatment, and the patient and organ survival rates remain at 100%.

After advancing to the use of primary human liver cells and the development of the Modular Extracorporeal Liver Support concept a further clinical pilot study was performed on 9 patients . 2/2 patients with acute liver failure (ALF) were successfully bridged to liver transplantation (LTx). 2/2 patients with acute-on-chronic (AoC) liver failure were successfully bridged to LTx. One of these patients died 3 weeks after transplantation following multi-organ failure. Two patients with AoC liver failure were not eligible for LTx due to continuing alcohol consumption: they were supported during a period of acute deterioration and one of them died three weeks after the last treatment. 3/3 patients were successfully bridged to re-transplantation after primary non-function of their liver graft. One patient with initial poor function was treated to recovery over periods of 73 h and 71 h. Another patient was totally hepatectomized and was subsquently supported over a period of 24 hours prior to re-transplantation. The overall treatment time was 7-144 hours. No adverse events were observed. In all cases of acute liver failure the patient's neurological status improved during treatment. After oligo-anuric kidney failure, recovery was noted and a slight improvement of coagulation status was seen.

  1. Sauer IM, Kardassis D, Zeilinger K, Pascher A, Gruenwald A, Pless G, Irgang M, Kraemer M, Puhl G, Frank J, Müller AR , Steinmüller T, Denner J, Neuhaus P, Gerlach JC: Clinical extracorporeal hybrid liver support – phase I study with primary porcine liver cells. Xenotransplantation; 2003, 10: 460-469
  2. Irgang M, Sauer IM, Karlas A, Zeilinger K, Gerlach JC, Kurth R, Neuhaus P, Denner J: Porcine endogenous retroviruses (PERVs): No infection in patients treated with a bioreactor based on porcine liver cells. Clinical Virology 2003, J Clin Virol; 2003, 28(2): 141-154
  3. Gerlach J, Zeilinger K, Sauer IM, Mieder T, Nauman G, Grünwald A, Pless G, Holland A, Mas A, Vienken J, Neuhaus P. Extracorporeal liver support: Porcine or human cell based systems? Int J Artif Org 2002; 25 (10): 1013-1019
  4. Sauer I, Gerlach J. Modular extracorporeal liver support. Art Org 2002; 26:703-706
  5. Sauer I, Gerlach J. Concept of modular extracorporeal liver support for treatment of acute hepatic failure. Journal of Metabolic Brain Disease 2002; 17 (4): 477-484
  6. Sauer IM, Zeilinger K, Obermayer N, Pless G, Pascher A, Mieder T, Roth S, Goetz M, Kardassis D, Mas A, Neuhaus P, Gerlach JC. Primary human liver cells as source for modular extracorporeal liver support – a preliminary report. Int J Art Org 2002; 25 (10): 1001-1006
  7. Sauer IM, Zeilinger K, Pless G, Kardassis D, Theruvath T, Pascher A, Mueller AR, Steinmueller T, Neuhaus P, Gerlach JC: Extracorporeal Liver Support based on Human Liver Cells and Albumin Dialysis – Treatment of a Patient with Primary Graft Non-Function. Journal of Hepatology 2003; 39(4): 649-653
Updated 1-August-2017