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Regenerative Medicine

Pedro S Couto, Alexey Bersenev, Frances Verter
AIM: The first review of advanced cell therapy trials with perinatal cells. MATERIALS & METHODS: We compiled 281 clinical trials of advanced cell therapy with perinatal cells that were registered in 2005-2015. RESULTS: The most common cell source in these trials is cord blood, but the cell type that provides the mechanism of action in the majority of trials is mesenchymal stem/stromal cells. We analyze trends among the 15 parameters we compiled for these trials...
November 15, 2017: Regenerative Medicine
Megan Munsie, Tamra Lysaght, Tereza Hendl, Hui-Yin Lynn Tan, Ian Kerridge, Cameron Stewart
AIM: This article examines online marketing practices of Japanese and Australian clinics offering putative autologous stem cell treatments. MATERIALS & METHODS: We conducted google searches for keywords related to stem cell therapy and stem cell clinics in English and Japanese. RESULTS: We identified websites promoting 88 point-of-sale clinics in Japan and 70 in Australia. CONCLUSION: Our findings provide further evidence of the rapid global growth in clinics offering unproven stem cell interventions...
November 10, 2017: Regenerative Medicine
Kathleen McNutt, Amy Zarzeczny
AIM: Our aim in this project was to explore Twitter's potential as a vehicle for an online public information campaign (PIC) focused on providing evidence-based information about stem cell therapies and the market for unproven stem cell-based interventions. METHODS: We designed an online, Twitter-based PIC using classic design principles and identified a set of target intermediaries (organizations with online influence) using a network governance approach. We tracked the PIC's dissemination over a 2-month period, and evaluated it using metrics from the #SMMStandards Conclave...
November 8, 2017: Regenerative Medicine
Mariele Viganò, Rosaria Giordano, Lorenza Lazzari
Advanced therapy medicinal products represent a new generation of medicinal products for regenerative medicine. Since the implementation of the EU regulation for this innovative class of drugs, the academic and hospital institutions have played a central role in their development and manufacture. For these institutions that are not familiar with the industrial context, being in compliance with the pharmaceutical standards is extremely challenging. This report describes how we dealt with some specific issues during our hospital-based GMP experience...
November 8, 2017: Regenerative Medicine
Claire Tanner, Alan Petersen, Megan Munsie
AIM: This article examines how those who contemplate purported stem cell treatments (SCTs) negotiate available information sources and the adequacy of current approaches to guidance and support. MATERIALS & METHODS: Qualitative interviews undertaken with people who had contemplated or undergone purported SCTs for a range of conditions (n = 24 and n = 27, respectively), as well as professionals who are frequently asked about SCTs (n = 20) were analyzed. RESULTS: Our findings reveal the difficulties for individuals in discriminating between different sources of information on SCTs and the limitations of current responses...
November 8, 2017: Regenerative Medicine
Alessandro R Marcon, Blake Murdoch, Timothy Caulfield
AIM: This study examines how stem cells and stem cell research are portrayed on websites deemed to be purveyors of distorted and dubious information. METHODS: Content analysis was conducted on 224 articles from 2015 to 2016, compiled by searching with the keywords 'stem cell(s)' on a list of websites flagged for containing either 'fake' or 'junk science' news. RESULTS: Articles contained various exaggerated positive and negative claims about stem cells and stem cell science, health and science related conspiracy theories, and statements promoting fear and mistrust of conventional medicine...
November 8, 2017: Regenerative Medicine
Douglas Sipp
Clinical application of autologous cells by businesses promoting unproven stem cell treatments represents the largest growth sector in this problematic industry, but also presents special challenges to regulators. Patients frequently identify autologous cells as personal property, using the language of 'ownership'. Through an analysis of comments submitted to the US FDA in 2016 in response to recent draft guidance documents, I show that a sense of ownership and identity in autologous cells is consistently expressed by stakeholders...
November 8, 2017: Regenerative Medicine
Jan Barfoot, Achim Rosemann, C Clare Blackburn
No abstract text is available yet for this article.
November 7, 2017: Regenerative Medicine
Shashank S Tiwari, Sujatha Raman, Paul Martin
The government of India has heavily promoted research and development in regenerative medicine together with domestic innovation and business development initiatives. Together, these promise a revolution in healthcare and public empowerment in India. Several national and transnational linkages have emerged to develop innovative capacity, most prominently in stem cell and cord blood banking, as well as in gene therapy, tissue engineering, biomaterials and 3D printing. However, challenges remain of achieving regulatory oversight, viable outputs and equitable impacts...
November 7, 2017: Regenerative Medicine
Amy Zarzeczny, Kathleen McNutt
No abstract text is available yet for this article.
November 7, 2017: Regenerative Medicine
Amit Prasad
No abstract text is available yet for this article.
November 2, 2017: Regenerative Medicine
John Gardner
Many countries have identified regenerative medicine as a strategic priority, and have thus launched a range of initiatives to facilitate innovation in the field. This perspective paper argues that several initiatives involve resource distributions that could impinge on widely accepted egalitarian notions of fairness and justice that underpin current healthcare systems. Specifically, this paper focuses on five initiatives, and argues that these initiatives reflect a largely unacknowledged utilitarian perspective on distributive justice...
November 2, 2017: Regenerative Medicine
Alison Williams, Ken Bowler, Bill Wright
No abstract text is available yet for this article.
November 2, 2017: Regenerative Medicine
Andrew Webster
This paper asks how regenerative medicine can be examined through the 'responsible research and innovation' (RRI) approach which has been developed over the past decade. It describes the drivers to the development of RRI, and then argues for the need to understand innovation itself through drawing on social science analysis rooted in science and technology studies. The paper then identifies a number of highly specific challenges faced by the regenerative medicine field and the implications these have for value creation...
November 2, 2017: Regenerative Medicine
Achim Rosemann, Jan Barfoot, Clare Blackburn
No abstract text is available yet for this article.
October 11, 2017: Regenerative Medicine
Shane A Shapiro, Jennifer R Arthurs
AIM: We review relevant anatomy of the iliac crest, and describe an interventional technique to maximize harvesting of desired progenitor cells with ultrasound to guide safe trochar placement. MATERIALS & METHODS: We validated the technique on both sides of the pelvis in four human cadavers. RESULTS: Using ultrasound guidance, 32 BMA needles were placed in a safe zone along various portions of the iliac crest. CONCLUSION: Ultrasound guidance can improve accuracy of bone marrow aspirations form the iliac crest...
September 11, 2017: Regenerative Medicine
(no author information available yet)
Since the following case report was found not to meet the ethical standards of Juntendo University, as previously stated by the authors, the article has been retracted from Regenerative Medicine: Kantake M, Hirano A, Sano M, Urushihata N, Tanemura H, Oki K, Suzaki E. Transplantation of allogeneic adipose-derived mesenchymal stem cells in a cerebral palsy patient. Regenerative Medicine doi:10.2217/rme-2017-0043 (2017) (Epub ahead of print). The authors and editors of Regenerative Medicine regret any negative consequences this publication might have caused in the scientific and medical communities...
September 5, 2017: Regenerative Medicine
Sarah Chan
Probably the most serious problem facing the field of regenerative medicine today is the challenge of effective translation and development of viable stem cell-based therapies. Particular concerns have been raised over the growing market in unproven cell therapies. In this article, I explore recent developments in the stem cell therapy landscape and argue that while the sale of unproven therapies undoubtedly poses ethical concerns, it must be understood as part of a larger problem at the interface between biomedicine, healthcare, publics, policy and the market...
October 2017: Regenerative Medicine
Barbara von Tigerstrom
There are widespread concerns with the ways in which 'unproven' stem cell therapies are advertised to patients. This article explores the potential and limits of using laws that regulate advertising and promotion as a tool to address these concerns. It examines general consumer protection laws and laws and policies on advertising medical products and services, focusing on the USA, Canada and Australia. The content of existing laws and policies covers most of the marketing practices that cause concern, but several systemic factors are likely to limit enforcement efforts...
October 2017: Regenerative Medicine
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