Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues

por Schröder, Hannes M., Niebergall-Roth, Elke, Norrick, Alexandra, Esterlechner, Jasmina, Ganss, Christoph, Frank, Markus H., Kluth, Mark A.
Publicado 2023

In vivo safety profile and biodistribution of GMP-manufactured human skin-derived ABCB5-positive mesenchymal stromal cells for use in clinical trials

por TAPPENBECK, NILS, SCHRÖDER, HANNES M., NIEBERGALL-ROTH, ELKE, HASSINGER, FATHEMA, DEHIO, ULF, DIETER, KATHRIN, KRAFT, KORINNA, KERSTAN, ANDREAS, ESTERLECHNER, JASMINA, FRANK, NATASHA Y., SCHARFFETTER-KOCHANEK, KARIN, MURPHY, GEORGE F., ORGILL, DENNIS P., BECK, JOACHIM, FRANK, MARKUS H., GANSS, CHRISTOPH, KLUTH, MARK A.
Publicado 2019

Process development and safety evaluation of ABCB5(+) limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency

por Norrick, Alexandra, Esterlechner, Jasmina, Niebergall-Roth, Elke, Dehio, Ulf, Sadeghi, Samar, Schröder, Hannes M., Ballikaya, Seda, Stemler, Nicole, Ganss, Christoph, Dieter, Kathrin, Dachtler, Ann-Kathrin, Merz, Patrick, Sel, Saadettin, Chodosh, James, Cursiefen, Claus, Frank, Natasha Y., Auffarth, Gerd U., Ksander, Bruce, Frank, Markus H., Kluth, Mark A.
Publicado 2021

Ex vivo-expanded highly pure ABCB5(+) mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process val...

por Kerstan, Andreas, Niebergall-Roth, Elke, Esterlechner, Jasmina, Schröder, Hannes M., Gasser, Martin, Waaga-Gasser, Ana M., Goebeler, Matthias, Rak, Katrin, Schrüfer, Philipp, Endres, Sabrina, Hagenbusch, Petra, Kraft, Korinna, Dieter, Kathrin, Ballikaya, Seda, Stemler, Nicole, Sadeghi, Samar, Tappenbeck, Nils, Murphy, George F., Orgill, Dennis P., Frank, Natasha Y., Ganss, Christoph, Scharffetter-Kochanek, Karin, Frank, Markus H., Kluth, Mark A.
Publicado 2020

Translational development of ABCB5(+) dermal mesenchymal stem cells for therapeutic induction of angiogenesis in non-healing diabetic foot ulcers

por Kerstan, Andreas, Dieter, Kathrin, Niebergall-Roth, Elke, Klingele, Sabrina, Jünger, Michael, Hasslacher, Christoph, Daeschlein, Georg, Stemler, Lutz, Meyer-Pannwitt, Ulrich, Schubert, Kristin, Klausmann, Gerhard, Raab, Titus, Goebeler, Matthias, Kraft, Korinna, Esterlechner, Jasmina, Schröder, Hannes M., Sadeghi, Samar, Ballikaya, Seda, Gasser, Martin, Waaga-Gasser, Ana M., Murphy, George F., Orgill, Dennis P., Frank, Natasha Y., Ganss, Christoph, Scharffetter-Kochanek, Karin, Frank, Markus H., Kluth, Mark A.
Publicado 2022

Allogeneic ABCB5(+) Mesenchymal Stem Cells for Treatment-Refractory Chronic Venous Ulcers: A Phase I/IIa Clinical Trial

por Kerstan, Andreas, Dieter, Kathrin, Niebergall-Roth, Elke, Dachtler, Ann-Kathrin, Kraft, Korinna, Stücker, Markus, Daeschlein, Georg, Jünger, Michael, Görge, Tobias, Meyer-Pannwitt, Ulrich, Erfurt-Berge, Cornelia, von Engelhardt, Charlotte, Klare, Andreas, Pfeiffer, Christiane, Esterlechner, Jasmina, Schröder, Hannes M., Gasser, Martin, Waaga-Gasser, Ana M., Goebeler, Matthias, Ballikaya, Seda, Sadeghi, Samar, Murphy, George F., Orgill, Dennis P., Frank, Natasha Y., Ganss, Christoph, Scharffetter-Kochanek, Karin, Frank, Markus H., Kluth, Mark A.
Publicado 2021