[HTML][HTML] 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 …

[图书][B] Articular cartilage tissue engineering

KA Athanasiou, EM Darling, JC Hu - 2010 - books.google.com
Cartilage injuries in children and adolescents are increasingly observed, with roughly 20%
of knee injuries in adolescents requiring surgery. In the US alone, costs of osteoarthritis (OA) …

[图书][B] Articular cartilage

KA Athanasiou, EM Darling, JC Hu, GD DuRaine… - 2017 - taylorfrancis.com
This book covers the latest research and advancements related to articular cartilage in
biology, development, pathology, clinical applications and tissue engineering. The authors …

From banking to international governance: fostering innovation in stem cell research

R Isasi, BM Knoppers - Stem Cells International, 2011 - Wiley Online Library
Stem cell banks are increasingly recognized as an essential resource of biological materials
for both basic and translational stem cell research. By providing transnational access to …

Industry perceptions of barriers to commercialization of regenerative medicine products in the UK

AC Plagnol, E Rowley, P Martin… - Regenerative Medicine, 2009 - Taylor & Francis
Aims: Regenerative medicine is an emerging field with the potential to provide widespread
improvement in healthcare and patient wellbeing via the delivery of therapies that can …

Wound stimulation by growth-arrested human keratinocytes and fibroblasts: HP802-247, a new-generation allogeneic tissue engineering product

R Goedkoop, R Juliet, PHK You, J Daroczy… - Dermatology, 2010 - karger.com
Background: HP802-247 is a new-generation, allogeneic tissue engineering product
consisting of growth-arrested, human keratinocytes (K) and fibroblasts (F) delivered in a …

Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics

G De Grandis, I Brass, SS Farid - Regulation & Governance, 2023 - Wiley Online Library
The need to better balance the promotion of scientific and technological innovation with risk
management for consumer protection has inspired several recent reforms attempting to …

The challenges of regulating stem cell-based products

BJ von Tigerstrom - Trends in biotechnology, 2008 - cell.com
Appropriate regulation of stem cell-based products is essential to ensure public safety and
trust while minimising unnecessary barriers to product development, but presents numerous …

[HTML][HTML] ATMP in practice: Towards a new industry landscape in tissue engineering

L Brévignon-Dodin, P Singh - Journal of Commercial Biotechnology, 2009 - Springer
Regulatory divergences and market fragmentation across member states have hampered
the development of the tissue engineering industry in the EU. Addressing this situation by …

Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU

L Brévignon-Dodin - Bio-Medical Materials and Engineering, 2010 - content.iospress.com
Abstract The EU Regulation on Advanced Therapy Medicinal Products (ATMP) bridges a
regulatory gap and is expected to act as an enabler for the regenerative medicine sector in …