日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

Dimethyl sulfoxide in cryopreserved mesenchymal stromal cell therapy products: is there a safety risk to patients?

冷冻保存的间充质干细胞治疗产品中的二甲基亚砜:对患者是否存在安全风险?

Niebergall-Roth, Elke; Kluth, Mark Andreas

Potency assay to predict the anti-inflammatory capacity of a cell therapy product for macrophage-driven diseases: overcoming the challenges of assay development and validation

用于预测细胞治疗产品对巨噬细胞驱动疾病的抗炎能力的效力测定:克服测定方法开发和验证的挑战

Sadeghi, Samar; Nimtz, Laura; Niebergall-Roth, Elke; Norrick, Alexandra; Hägele, Stefan; Vollmer, Lena; Esterlechner, Jasmina; Frank, Markus H; Ganss, Christoph; Scharffetter-Kochanek, Karin; Kluth, Mark Andreas

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

针对细胞治疗产品生物分析研究,特别关注多种器官组织中基质干扰的qPCR检测方法的药物监管合规性验证

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

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

ABCB5+ 真皮间充质干细胞的转化开发,用于治疗非愈合性糖尿病足部溃疡的血管生成

Andreas Kerstan #, Kathrin Dieter #, Elke Niebergall-Roth #, Sabrina Klingele, Michael Jünger, Christoph Hasslacher, Georg Daeschlein, Lutz Stemler, Ulrich Meyer-Pannwitt, Kristin Schubert, Gerhard Klausmann, Titus Raab, Matthias Goebeler, Korinna Kraft, Jasmina Esterlechner, Hannes M Schröder, Sama

Clinical trial of ABCB5+ mesenchymal stem cells for recessive dystrophic epidermolysis bullosa

ABCB5+间充质干细胞治疗隐性营养不良性大疱性表皮松解症的临床试验

Dimitra Kiritsi, Kathrin Dieter, Elke Niebergall-Roth, Silvia Fluhr, Cristina Daniele, Jasmina Esterlechner, Samar Sadeghi, Seda Ballikaya, Leoni Erdinger, Franziska Schauer, Stella Gewert, Martin Laimer, Johann W Bauer, Alain Hovnanian, Giovanna Zambruno, May El Hachem, Emmanuelle Bourrat, Maria Pa

Ex vivo-expanded highly pure ABCB5+ mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process validation and first in-human data

体外扩增的高纯度 ABCB5+ 间充质基质细胞作为符合良好生产规范的自体先进治疗药物用于临床:工艺验证和首批人体数据

Andreas Kerstan, Elke Niebergall-Roth, Jasmina Esterlechner, Hannes M Schröder, Martin Gasser, Ana M Waaga-Gasser, Matthias Goebeler, Katrin Rak, Philipp Schrüfer, Sabrina Endres, Petra Hagenbusch, Korinna Kraft, Kathrin Dieter, Seda Ballikaya, Nicole Stemler, Samar Sadeghi, Nils Tappenbeck, George

Process data of allogeneic ex vivo-expanded ABCB5+ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP

供人类使用的同种异体体外扩增的 ABCB5+ 间充质基质细胞的工艺数据:现成的 GMP 制造的不依赖供体的 ATMP

Seda Ballikaya, Samar Sadeghi, Elke Niebergall-Roth, Laura Nimtz, Jens Frindert, Alexandra Norrick, Nicole Stemler, Nicole Bauer, Yvonne Rosche, Vanessa Kratzenberg, Julia Pieper, Tina Ficek, Markus H Frank, Christoph Ganss, Jasmina Esterlechner, Mark A Kluth

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

用于临床试验的 GMP 制造的人类皮肤来源的 ABCB5 阳性间充质基质细胞的体内安全性和生物分布

Nils Tappenbeck, Hannes M Schröder, Elke Niebergall-Roth, Fathema Hassinger, Ulf Dehio, Kathrin Dieter, Korinna Kraft, Andreas Kerstan, Jasmina Esterlechner, Natasha Y Frank, Karin Scharffetter-Kochanek, George F Murphy, Dennis P Orgill, Joachim Beck, Markus H Frank, Christoph Ganss, Mark A Kluth