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Regenerative Medicine

Paul S Knoepfler, Leigh G Turner
Hundreds of businesses in the US currently advertise a wide range of non-US FDA-approved stem cell interventions. Here we present a novel systematic temporal analysis of US companies engaged in direct-to-consumer marketing of putative stem cell treatments. Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90-100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited...
January 12, 2018: Regenerative Medicine
Curtis O Asante, Francesco Dazzi
No abstract text is available yet for this article.
December 15, 2017: Regenerative Medicine
Alain A Vertès
Medicinal signaling cell (MSC)-based products represent emerging treatments in various therapeutic areas including cardiometabolic, inflammation, autoimmunity, orthopedics, wound healing and oncology. Exploring innovation beyond minimally manipulated plastic-adherent ex vivo expanded allogeneic MSCs enables product delineation. Product delineation is on the critical path to maximize clinical benefits and market access. An innovation framework is presented here along various innovation dimensions comprising composition-of-matter by means of positive cell surface markers, formulation varying for example the cell dose or the preservation mode and medium, manufacturing to adapt the secretome of MSCs to the condition of interest, the mode of delivery and corresponding delivery devices, as well as molecular engineering and biomarkers...
December 15, 2017: Regenerative Medicine
Houria Bachtarzi
Recent advances in human genome science have paved the way to a new class of human gene therapies based on gene editing, with the potential to provide a long-lasting curative strategy for many debilitating and complex disorders, for which there is an unmet medical need. Therapeutic genome editing encompasses both ex vivo and in vivo gene correction modalities, for which similar and also application-specific considerations apply, which dictate the overall strategy to be followed from a scientific, clinical and regulatory perspective...
December 15, 2017: Regenerative Medicine
Adiv A Johnson, Cynthia Andrews-Pfannkoch, Timothy J Nelson, Jose S Pulido, Alan D Marmorstein
The comparison of differentiated induced pluripotent stem cells (iPSCs) derived from patients with disease to differentiated iPSCs derived from healthy patients enables powerful disease modeling. By performing an informal retrospective survey of disease modeling studies published in high impact journals, we found that the median and average number of controls used in these studies were 1 and 1.6, respectively. The bulk of these studies did not control for age, gender and ethnicity. Since a large proportion of phenotypic differences observed between iPSC lines are due to genetic variation or variation between lines, this is an insufficient number of controls to confidently rule out standard variation...
December 15, 2017: Regenerative Medicine
Fahimeh S Tabatabaei, Jafar Ai
Hard tissues including teeth, bone and cartilage have inability or poor capacity to self-renew, especially in large defects. Therefore, repair of damages in these tissues represents a huge challenge in the medical field today. Hard tissue engineering commonly utilizes different stem cell sources as a promising strategy for treating bone, cartilages and tooth defects or disorders. Decades ago, researchers successfully isolated and identified endometrial mesenchymal stem/stromal cells (EnSCs) and discovered their multidifferentiation potential...
December 7, 2017: Regenerative Medicine
Mark W Maxfield, Mitchel R Stacy, Hirotsugu Kurobe, Shuhei Tara, Tai Yi, Muriel A Cleary, Zhen W Zhuang, Manuel I Rodriguez-Davalos, Sukru H Emre, Yasuko Iwakiri, Toshiharu Shinoka, Christopher K Breuer
AIM: Surgical management of pediatric extrahepatic portal vein obstruction requires meso-Rex bypass using autologous or synthetic grafts. Tissue-engineered vascular grafts (TEVGs) provide an alternative, but no validated animal models using portal TEVGs exist. Herein, we preclinically assess TEVGs as portal vein bypass grafts. MATERIALS & METHODS: TEVGs were implanted as portal vein interposition conduits in SCID-beige mice, monitored by ultrasound and micro-computed tomography, and histologically assessed postmortem at 12 months...
December 7, 2017: Regenerative Medicine
Kayo Takashima, Yusuke Inoue, Shimon Tashiro, Kaori Muto
No abstract text is available yet for this article.
December 6, 2017: Regenerative Medicine
Chiara Gm Gennari, Francesco Cilurzo, Nico Mitro, Donatella Caruso, Paola Minghetti, Valerio Magnaghi
AIM: This in vitro and in vivo study reports on silk fibroin (SF) scaffold, functionalized for in situ delivery of GABA and/or allopregnanolone (ALLO), as biomaterial for potential application in tissue engineering and nerve regeneration. MATERIALS & METHODS: We evaluated the feasibility to design 2D scaffolds (films) made of regenerated Bombyx mori SF, functionalized with GABA and/or ALLO to enhance in vitro biological functions, health, survival and growth of Schwann cells and sensitive neurons of the dorsal root ganglia...
November 21, 2017: 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
Jan Barfoot, Achim Rosemann, C Clare Blackburn
No abstract text is available yet for this article.
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
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