Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations

A Rosemann, G Bortz, F Vasen… - Regenerative …, 2016 - Taylor & Francis
In this article, we explore regulatory developments in stem cell medicine in seven
jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that …

New regulation for clinical stem cell research in China: expected impact and challenges for implementation

A Rosemann, M Sleeboom-Faulkner - Regenerative medicine, 2016 - Taylor & Francis
Commentary Rosemann & Sleeboom-Faulkner online at the Chinese Medicine Registry and
Management System. The NHFPC and CFDAs will jointly review the projects at a provincial …

The global landscape of stem cell clinical trials

MD Li, H Atkins, T Bubela - Regenerative medicine, 2014 - Taylor & Francis
Aim: To provide a comprehensive analysis of clinical trials (CTs) listed in worldwide
registries involving new applications for stem cell-based treatments and account for the role …

Regulatory developments for nonhematopoietic stem cell therapeutics: perspectives from the EU, the USA, Japan, China, India, Argentina, and Brazil

A Rosemann, G Bortz, F Vasen - A Roadmap to Non-Hematopoietic Stem …, 2019 - Elsevier
This chapter explores regulatory developments for nonhematopoietic stem cell therapies in
Japan, China, India, Argentina, Brazil, the USA, and the European Union. The chapter …

[HTML][HTML] Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine

A Rosemann - Social Science & Medicine, 2014 - Elsevier
The article examines the role and challenges of scientific self-governance and
standardization in inter-continental clinical research partnerships in stem cell medicine. The …

Unproven stem cell interventions: a global public health problem requiring global deliberation

Z Master, KRW Matthews, M Abou-el-Enein - Stem Cell Reports, 2021 - cell.com
The unproven stem cell intervention (SCI) industry is a global health problem. Despite efforts
of some nations, the industry continues to flourish. In this paper, we call for a global …

Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial

C Hauskeller - Regenerative Medicine, 2017 - Taylor & Francis
Harmonized regulation of research with human stem cells in Europe has shaped innovation
in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous …

Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials

E Kleiderman, A Boily, C Hasilo… - Stem cell research & …, 2018 - Springer
In the context of regenerative medicine and cellular therapies, the treatment under study
often targets a less common disease or condition for which recruitment of a large number of …

From bench to FDA to bedside: US regulatory trends for new stem cell therapies

PS Knoepfler - Advanced drug delivery reviews, 2015 - Elsevier
The phrase “bench-to-bedside” is commonly used to describe the translation of basic
discoveries such as those on stem cells to the clinic for therapeutic use in human patients …

Inclusivity and diversity: Integrating international perspectives on stem cell challenges and potential

R Fears, H Akutsu, LT Alentajan-Aleta, A Caicedo… - Stem Cell Reports, 2021 - cell.com
Regenerative medicine has great potential. The pace of scientific advance is exciting and
the medical opportunities for regeneration and repair may be transformative. However …