title: Stem cell therapy clinical research: A regulatory conundrum for academia.
abstract: The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety.
authors.affiliation: Stroke Research Programme, School of Medicine, Faculty of Health Sciences, The University of Adelaide, Level 6 South, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000, Australia. Electronic address: anjali.nagpal@adelaide.edu.au.
authors.forename: Anjali
authors.initials: A
authors.lastname: Nagpal
authors.affiliation: Stroke Research Programme, School of Medicine, Faculty of Health Sciences, The University of Adelaide, Level 6 South, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000, Australia. Electronic address: cjuttner@bigpond.net.au.
authors.forename: Chris
authors.initials: C
authors.lastname: Juttner
authors.affiliation: Stroke Research Programme, School of Medicine, Faculty of Health Sciences, The University of Adelaide, Level 6 South, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000, Australia; Neurology, Central Adelaide Local Health Network (CALHN), Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000, Australia; School of Medicine, Faculty of Health Sciences, The University of Adelaide, Adelaide, SA 5005, Australia. Electronic address: Anne.Hamilton-Bruce@health.sa.gov.au.
authors.forename: Monica Anne
authors.initials: MA
authors.lastname: Hamilton-Bruce
authors.affiliation: School of Medicine, Faculty of Health Sciences, The University of Adelaide, Adelaide, SA 5005, Australia. Electronic address: paul.rolan@adelaide.edu.au.
authors.forename: Paul
authors.initials: P
authors.lastname: Rolan
authors.affiliation: Stroke Research Programme, School of Medicine, Faculty of Health Sciences, The University of Adelaide, Level 6 South, South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000, Australia; Neurology, Central Adelaide Local Health Network (CALHN), Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000, Australia; School of Medicine, Faculty of Health Sciences, The University of Adelaide, Adelaide, SA 5005, Australia. Electronic address: simon.koblar@adelaide.edu.au.
authors.forename: Simon A
authors.initials: SA
authors.lastname: Koblar
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D006801:Humans; D044968:Regenerative Medicine; D033581:Stem Cell Transplantation
keywords: Academic research; Cell therapy; Innovative medical practice; Regenerative medicine; Regulatory policy