Article
Cell Biology
Chantal Lechanteur, Alexandra Briquet, Virginie Bettonville, Etienne Baudoux, Yves Beguin
Summary: The study outlines the upgrade of an existing clinical-grade MSC manufacturing process to comply with GMP standards, including reorganization of key aspects and validation of a new variant for specific disease treatment. While GMP manufacturing of MSC products is feasible in academic settings, large-scale production for phase III trials would require collaboration with industrial partners.
Review
Medicine, General & Internal
Paula Salmikangas, Bjorn Carlsson, Christophe Klumb, Tatiana Reimer, Steffen Thirstrup
Summary: Potency is a critical quality attribute of biological medicinal products that reflects their biological activity. For timely release and comparability studies, quantitative in vitro assays are necessary. Cell and Gene Therapy Products (CGTs) present challenges in potency testing due to their complexity.
FRONTIERS IN MEDICINE
(2023)
Review
Pharmacology & Pharmacy
Marina Lopez-Paniagua, Ana de la Mata, Sara Galindo, Francisco Blazquez, Margarita Calonge, Teresa Nieto-Miguel
Summary: ATMPs are innovative and complex biological products for human use, including cell therapy, tissue engineering, gene therapy, and combined products with medical devices. The development of ATMPs for treating eye diseases has rapidly expanded in recent years, offering novel therapeutic approaches for incurable conditions.
Article
Cell & Tissue Engineering
Maria Martin-Lopez, Cristina Rosell-Valle, Blanca Arribas-Arribas, Beatriz Fernandez-Munoz, Rosario Jimenez, Sonia Nogueras, Ana Belen Garcia-Delgado, Fernando Campos, Monica Santos-Gonzalez
Summary: This study evaluated cryoprotective formulations based on human platelet lysate (hPL) for the cryopreservation of bioengineered tissues and cell therapy products. The results showed that the Ti5 and CeA formulations were efficient and safe candidates that could replace commercially available cryoprotective solutions, offering a xeno-free and low-DMSO alternative.
STEM CELL RESEARCH & THERAPY
(2023)
Article
Medicine, General & Internal
Sebastian Haeusner, Laura Herbst, Patrick Bittorf, Thomas Schwarz, Chris Henze, Marc Mauermann, Jelena Ochs, Robert Schmitt, Ulrich Blache, Anke Wixmerten, Sylvie Miot, Ivan Martin, Oliver Pullig
Summary: ATMP, particularly TEPs, offer promising treatment options for unmet clinical needs, but face challenges of high manufacturing costs and labor-intensive processes. Automation has the potential to overcome these obstacles, but requires effective cleaning procedures and process control. Innovative technologies and concepts can address current manufacturing hurdles in ATMP production.
FRONTIERS IN MEDICINE
(2021)
Review
Biotechnology & Applied Microbiology
Laura Chastagnier, Christophe Marquette, Emma Petiot
Summary: Gene transfection has been widely used in various research fields, bioproduction, and therapy to induce the expression of target genes. Current transfection protocols mainly focus on 2D adherent cells or suspension cultures, but there is a growing need for in situ transfection of tissues and 3D cell cultures in the field of gene therapy and regenerative medicine.
BIOTECHNOLOGY ADVANCES
(2023)
Review
Biotechnology & Applied Microbiology
Astgik Petrosyan, Paulo. N. N. Martins, Kim Solez, Basak. E. E. Uygun, Vijay. S. S. Gorantla, Giuseppe Orlando
Summary: Insights into the use of cellular therapeutics, extracellular vesicles (EVs), and tissue engineering strategies for regenerative medicine applications are continually emerging. These approaches have shown strong potential in modulating inflammatory immune responses, promoting regeneration in diseased organs, and treating inflammatory diseases like COVID-19. The field of stem cell therapies, in particular, has seen significant advancements in understanding stem cell heterogeneity and dosage specificity, leading to expanded clinical applications. Standardizing manufacturing protocols for tissue-engineered grafts is a crucial step towards whole organ engineering. Despite challenges, the prospects for personalized regenerative and transplant medicine are promising.
FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY
(2022)
Editorial Material
Biotechnology & Applied Microbiology
Stuart Beattie
Summary: Compliance with GMO requirements for ATMPs in EU Member States varies significantly, leading to delays in clinical trials and making it difficult to conduct multicenter trials. The European Commission should consider simplifying regulations to improve access to gene therapies for European patients.
HUMAN GENE THERAPY
(2021)
Article
Cell & Tissue Engineering
Xiaoke Li, Dijun Li, Jiarong Li, Guishan Wang, Lei Yan, Haifeng Liu, Jingwei Jiu, Jiao Jiao Li, Bin Wang
Summary: This review provides an up-to-date and comprehensive overview of preclinical and clinical studies that tested cell-based treatments for meniscus regeneration. It presents novel perspectives on studies published in the past 30 years, giving consideration to the cell sources and dose selection, delivery methods, extra stimulation, animal models and injury patterns, timing of outcome assessment, and histological and biomechanical outcomes, as well as a summary of findings for individual studies. These unique insights will help to shape future research on the repair of meniscus lesions and inform the clinical translation of new cell-based tissue engineering strategies.
TISSUE ENGINEERING PART B-REVIEWS
(2023)
Review
Immunology
Chiara Capelli, Carolina Cuofano, Chiara Pavoni, Simona Frigerio, Daniela Lisini, Sara Nava, Michele Quaroni, Valentina Colombo, Francesco Galli, Svetlana Bezukladova, Paola Panina-Bordignon, Giuseppe Gaipa, Patrizia Comoli, Giulio Cossu, Gianvito Martino, Andrea Biondi, Martino Introna, Josee Golay
Summary: Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development. Potency assays are crucial for assessing the quality of ATMPs, and biomarkers may serve as substitutes for complex functional potency tests in predicting the efficacy of these cell-based drugs in vivo.
FRONTIERS IN IMMUNOLOGY
(2023)
Article
Engineering, Biomedical
Kevin Collon, Jennifer A. Bell, Stephanie W. Chang, Matthew C. Gallo, Osamu Sugiyama, Carolyn Marks, Jay R. Lieberman
Summary: This study compared different cell seeding techniques in transduced cell-based gene therapy. Static and negative pressure seeding techniques showed the highest seeding efficiency, while orbital shaking resulted in the greatest increase in BMP-2 production per cell. Low density cell suspensions were associated with the highest seeding efficiency, cell distribution uniformity, and the greatest increase in BMP-2 production after seeding.
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A
(2022)
Article
Biochemistry & Molecular Biology
Daniela Celeste Profico, Maurizio Gelati, Daniela Ferrari, Giada Sgaravizzi, Claudia Ricciolini, Massimo Projetti Pensi, Gianmarco Muzi, Laura Cajola, Massimiliano Copetti, Emilio Ciusani, Raffaele Pugliese, Fabrizio Gelain, Angelo Luigi Vescovi
Summary: Translating cell therapies into clinical practice requires robust production protocols to optimize and standardize cell manufacture and cryopreservation in compliance with regulations. Two phase I clinical trials were conducted on ALS and SPMS patients using human neural stem cells, produced from brain tissue samples extracted from fetuses. Rigorous quality control measures were implemented to ensure safety, stability, and reproducibility of the cells used in the trials.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Chemistry, Multidisciplinary
Yuxuan Yu, Sicen Lin, Zhichao Chen, Bin Qin, Zhonggui He, Maosheng Cheng, Mengchi Sun, Jin Sun
Summary: Throughout history, natural bacteria have been used to maintain human body's homeostasis and relieve diseases. With the advancement of genetic engineering and synthetic materials modification, hybrid bacteria have been developed to treat various diseases including obesity, gastrointestinal disorders, and cancers. This review discusses the characteristics and applications of natural bacteria-based drugs, as well as different conjugation methods and fate of hybrid bacteria in vivo. The importance and feasibility of therapeutic bacteria-based complex disease treatments are also emphasized, along with the challenges in clinical applications of bacterial drugs and potential solutions.
Review
Clinical Neurology
Ben Jiahe Gu, David K. Kung, Han-Chiao Isaac Chen
Summary: Cell therapy is seen as a promising strategy in enhancing recovery for stroke survivors, yet successful clinical translation remains elusive. This study highlights a mechanistic shift in cell therapy trials from replacing dead neurons in early studies to focusing on neuromodulation effects in later studies, emphasizing that both mechanisms are worth pursuing. It also stresses the importance of finding ways to achieve cell replacement in stroke treatment.
Review
Cell Biology
Venkata Suresh Venkataiah, Yoshio Yahata, Akira Kitagawa, Masahiko Inagaki, Yusuke Kakiuchi, Masato Nakano, Shigeto Suzuki, Keisuke Handa, Masahiro Saito
Summary: Bone tissue engineering involves combining MSCs with a biocompatible scaffold to aid in bone regeneration and recovery. While promising results have been seen in clinical trials, regenerating large bone defects remains a challenge.
Review
Cell & Tissue Engineering
Paula Salmikangas, Margarida Menezes-Ferreira, Ilona Reischl, Asterios Tsiftsoglou, Jan Kyselovic, John Joseph Borg, Sol Ruiz, Egbert Flory, Jean-Hugues Trouvin, Patrick Celis, Janis Ancans, Marcos Timon, Guido Pante, Dariusz Sladowski, Metoda Lipnik-Stangelj, Christian K. Schneider
REGENERATIVE MEDICINE
(2015)
Article
Biochemical Research Methods
Wojciech Krauze, Arkadiusz Kus, Dariusz Sladowski, Ewa Skrzypek, Malgorzata Kujawinska
Article
Immunology
Ewa Wilczek, Aleksander Wasiutynski, Grzegorz M. Wilczynski, Dariusz Sladowski, Barbara Gornicka
CENTRAL EUROPEAN JOURNAL OF IMMUNOLOGY
(2013)
Article
Immunology
Ewa Wilczek, Aleksander Wasiutynski, Dariusz Sladowski, Grzegorz M. Wilczynski, Barbara Gornicka
CENTRAL EUROPEAN JOURNAL OF IMMUNOLOGY
(2013)
Article
Oncology
Ewa Wilczek, Robert Rzepko, Dominika Nowis, Magdalena Legat, Jakub Golab, Marta Glab, Adam Gorlewicz, Filip Konopacki, Michal Mazurkiewicz, Dariusz Sladowski, Barbara Gornicka, Aleksander Wasiutynski, Grzegorz M. Wilczynski
INTERNATIONAL JOURNAL OF CANCER
(2008)
Article
Pharmacology & Pharmacy
Ryszard Galus, Justyna Niderla, Dariusz Sladowski, Emir Sajjad, Krzysztof Wlodarski, Jaroslaw Jozwiak
PHARMACOLOGICAL REPORTS
(2010)
Article
Medicine, General & Internal
Cecile F. Rousseau, Romaldas Maciulaitis, Dariusz Sladowski, Gopalan Narayanan
FRONTIERS IN MEDICINE
(2018)
Article
Medicine, Research & Experimental
Dariusz Sladowski, Iwona Grabska-Liberek, Joanna Olkowska-Truchanowicz, Kamil Lipski, Grzegorz Gut
ATLA-ALTERNATIVES TO LABORATORY ANIMALS
(2008)
Article
Medicine, Research & Experimental
Hans-Juergen Ahr, Nathalie Alepee, Siegfried Breier, Cornelis Brekelmans, Ian Cotgreave, Laura Gribaldo, Gianni Dal Negro, Odile De Silva, Thomas Hartung, Antonio Lacerda, Bernard Leblanc, Catherine Lecerf, Jens P. Linge, Susanna Louhimies, Irene Manou, Gavin Maxwell, Karsten K. Mueller, Wolfang Pape, Keith Redhead, Klaus R. Schroeder, Dariusz Sladowski, Katinka van der Jagt, Phillipe Vanparys
ATLA-ALTERNATIVES TO LABORATORY ANIMALS
(2008)
Article
Immunology
G. Gut, D. Sladowski
TRANSPLANTATION PROCEEDINGS
(2007)
Article
Immunology
Ireneusz Nawrot, Bogdan Wozniewicz, Tadeusz Tolloczko, Andrzej Sawicki, Andrzej Gorski, Witold Chudzinski, Mikolaj Wojtaszek, Wieslaw Grzesiuk, Dariusz Sladowski, Jerzy Karwacki, Teresa Zawitkowska, Jacek Szmidt
Article
Toxicology
D Sladowski, I Liberek, K Lipski, T Ozga, J Olkowska-Truchanowicz, J Szaflik
TOXICOLOGY IN VITRO
(2005)
Article
Toxicology
D Sladowski, R Combes, J van der Valk, I Nawrot, G Gut
TOXICOLOGY IN VITRO
(2005)
Article
Biochemistry & Molecular Biology
Dariusz Sladowski, Aleksander Wasiutynski, Grzegorz Wilczynski, Wona Grabska-Liberek, Sandra Coecke, Agnieszka Kinser, Iwona Kochanowska
FOLIA HISTOCHEMICA ET CYTOBIOLOGICA
(2006)