Commercialization of regenerative-medicine therapies

T Takahashi, RP Donahue, RC Nordberg… - Nature Reviews …, 2023 - nature.com
The clinical translation of regenerative-medicine products, including cell therapies,
therapeutic tissue engineering products, and human cell and tissue products, remains …

The ethical implications of tissue engineering for regenerative purposes: A systematic review

AFJ de Kanter, KR Jongsma, MC Verhaar… - … Engineering Part B …, 2023 - liebertpub.com
Tissue Engineering (TE) is a branch of Regenerative Medicine (RM) that combines stem
cells and biomaterial scaffolds to create living tissue constructs to restore patients' organs …

Advanced therapy medicinal products' translation in Europe: a developers' perspective

M Pizevska, J Kaeda, E Fritsche, H Elazaly… - Frontiers in …, 2022 - frontiersin.org
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-
engineered therapies have demonstrated enormous therapeutic benefits. However, their …

Cell-based medicinal products approved in the European Union: current evidence and perspectives

S Bellino, A La Salvia, MF Cometa… - Frontiers in …, 2023 - frontiersin.org
Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting
the pharmacological, immunological, or metabolic properties of cells and/or gene (s) with the …

Evolution of mesenchymal stem cell therapy as an advanced therapeutic medicinal product (ATMP)—an indian perspective

S Muthu, M Jeyaraman, MB Kotner, N Jeyaraman… - Bioengineering, 2022 - mdpi.com
Stem cells can be defined as the cells that have the capacity to both self-renew and give rise
to differentiated cells. Under the right conditions and signals, depending on their origin and …

[HTML][HTML] Early-phase clinical trials of bio-artificial organ technology: a systematic review of ethical issues

D de Jongh, EK Massey, AJ Cronin… - Transplant …, 2022 - frontierspartnerships.org
Regenerative medicine has emerged as a novel alternative solution to organ failure which
circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs …

GMP-grade manufacturing and quality control of a non-virally engineered advanced therapy medicinal product for personalized treatment of age-related macular …

M Kropp, N Harmening, T Bascuas, S Johnen… - Biomedicines, 2022 - mdpi.com
The introduction of new therapeutics requires validation of Good Manufacturing Practice
(GMP)-grade manufacturing including suitable quality controls. This is challenging for …

Implementation of mDoE‐methods to a microcarrier‐based expansion processes for mesenchymal stem cells

KB Kuchemüller, R Pörtner, J Möller - Biotechnology Progress, 2024 - Wiley Online Library
The need for advanced therapy medicinal products (ATMPs) has gained increased attention
in recent years. In this respect, a well‐designed cell expansion process is needed to …

Perinatal derivatives application: Identifying possibilities for clinical use

F Gindraux, N Hofmann, M Agudo-Barriuso… - … in Bioengineering and …, 2022 - frontiersin.org
Perinatal derivatives are drawing growing interest among the scientific community as an
unrestricted source of multipotent stromal cells, stem cells, cellular soluble mediators, and …

Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience

M Umemura, M Morrison - Regenerative Medicine, 2021 - Taylor & Francis
This paper explores how 'regenerative readiness' varies between different national research
and healthcare systems. Here,'readiness' refers to both the readiness of a given technology …