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https://www.readbyqxmd.com/read/27404768/comparability-manufacturing-characterization-and-controls-report-of-a-uk-regenerative-medicine-platform-pluripotent-stem-cell-platform-workshop-trinity-hall-cambridge-14-15-september-2015
#1
David J Williams, Richard Archer, Peter Archibald, Ioannis Bantounas, Ricardo Baptista, Roger Barker, Jacqueline Barry, Florence Bietrix, Nicholas Blair, Julian Braybrook, Jonathan Campbell, Maurice Canham, Amit Chandra, Gabor Foldes, Rudy Gilmanshin, Mathilde Girard, Erwin Gorjup, Zöe Hewitt, Paul Hourd, Johan Hyllner, Helen Jesson, Jasmin Kee, Julie Kerby, Nina Kotsopoulou, Stanley Kowalski, Chris Leidel, Damian Marshall, Louis Masi, Mark McCall, Conor McCann, Nicholas Medcalf, Harry Moore, Hiroki Ozawa, David Pan, Malin Parmar, Anne L Plant, Yvonne Reinwald, Sujith Sebastian, Glyn Stacey, Robert J Thomas, Dave Thomas, Jamie Thurman-Newell, Marc Turner, Loriana Vitillo, Ivan Wall, Alison Wilson, Jacqueline Wolfrum, Ying Yang, Heiko Zimmerman
This paper summarizes the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequently to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication states that this 'may be difficult for cell-based medicinal products'. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early...
July 2016: Regenerative Medicine
https://www.readbyqxmd.com/read/27156445/adipose-derived-stem-cells-counteract-urethral-stricture-formation-in-rats
#2
Fabio Castiglione, Karel Dewulf, Lukman Hakim, Emmanuel Weyne, Francesco Montorsi, Andrea Russo, Luca Boeri, Trinity J Bivalacqua, Dirk De Ridder, Steven Joniau, Maarten Albersen, Petter Hedlund
BACKGROUND: A medical treatment for urethral stricture (US) is not yet available. OBJECTIVE: To evaluate if local injection of human adipose tissue-derived stem cells (hADSC) prevents urethral fibrosis in a rat model of US. DESIGN, SETTING, AND PARTICIPANTS: Male rats were divided into three groups: sham, US, and hADSC (n=12 each). Sham rats received a vehicle injection in the urethral wall. US and hADSCs were incised and injected with the fibrosis-inducer transforming growth factor-β1 in the urethral wall...
May 3, 2016: European Urology
https://www.readbyqxmd.com/read/26967986/a-comparison-of-commercially-available-demineralized-bone-matrices-with-and-without-human-mesenchymal-stem-cells-in-a-rodent-spinal-fusion-model
#3
Tetsuo Hayashi, Elizabeth L Lord, Akinobu Suzuki, Shinji Takahashi, Trevor P Scott, Kevin Phan, Haijun Tian, Michael D Daubs, Keiichiro Shiba, Jeffrey C Wang
OBJECTIVE The efficacy of some demineralized bone matrix (DBM) substances has been demonstrated in the spinal fusion of rats; however, no previous comparative study has reported the efficacy of DBM with human mesenchymal stem cells (hMSCs). There is an added cost to the products with stem cells, which should be justified by improved osteogenic potential. The purpose of this study is to prospectively compare the fusion rates of 3 different commercially available DBM substances, both with and without hMSCs. METHODS Posterolateral fusion was performed in 32 mature athymic nude rats...
July 2016: Journal of Neurosurgery. Spine
https://www.readbyqxmd.com/read/26383039/use-of-regenerative-tissue-for-urinary-diversion
#4
REVIEW
Nikolai A Sopko, Max Kates, Trinity J Bivalacqua
PURPOSE OF REVIEW: There is a large interest in developing tissue engineered urinary diversions (TEUDs) in order to reduce the significant morbidity that results from utilization of the alimentary tract in the urinary system. Preclinical trials have been favorable but durable clinical results have not been realized. The present article will review the pertinent concepts for the clinical development of a successful TEUD. RECENT FINDINGS: Studies continue to identify novel scaffold materials and cell populations that are combined to generate TEUDs...
November 2015: Current Opinion in Urology
https://www.readbyqxmd.com/read/25868558/landmarks-in-erectile-function-recovery-after-radical-prostatectomy
#5
REVIEW
Emmanuel Weyne, Fabio Castiglione, Frank Van der Aa, Trinity J Bivalacqua, Maarten Albersen
The description of the nerve-sparing technique of radical prostatectomy by Walsh was one of the major breakthroughs in the surgical treatment of prostate cancer in the 20(th) century. However, despite this advance and consequent technological refinements to nerve-sparing surgery, a large proportion of men still suffer from erectile dysfunction (ED) as a complication of prostatectomy. A plethora of therapeutic approaches have been proposed to optimize erectile function recovery in these patients. Several preclinical and translational studies have shown benefits of therapies including PDE5 inhibitor (PDE5I) treatment, immunomodulation, neurotrophic factor administration, and regenerative techniques, such as stem cell therapy, in animal models...
May 2015: Nature Reviews. Urology
https://www.readbyqxmd.com/read/25356281/expression-of-a-distinct-set-of-chemokine-receptors-in-adipose-tissue-derived-stem-cells-is-responsible-for-in-vitro-migration-toward-chemokines-appearing-in-the-major-pelvic-ganglion-following-cavernous-nerve-injury
#6
Maarten Albersen, Joost Berkers, Philip Dekoninck, Jan Deprest, Tom F Lue, Petter Hedlund, Ching-Shwun Lin, Trinity J Bivalacqua, Hendrik Van Poppel, Dirk De Ridder, Frank Van der Aa
INTRODUCTION: Adipose tissue-derived stem cells (ADSCs) herald tremendous promise for clinical application in a wide range of injuries and diseases. Several preclinical reports demonstrate their efficacy in the treatment of cavernous nerve (CN) injury-induced erectile dysfunction in rats. It was recently illustrated that these effects were established as a result of ADSC migration to the major pelvic ganglion (MPG) where these cells induced neuroregeneration in loco. AIMS: The study aims to identify chemotactic factors in the MPG following injury and to match upregulated chemokines to their respective receptors in human ADSC on the genomic, structural, and functional levels...
August 2013: Sexual Medicine
https://www.readbyqxmd.com/read/23265388/reply-from-authors-re-ching-shwun-lin-tom-f-lue-adipose-derived-stem-cells-for-the-treatment-of-peyronie-s-disease-eur-urol-2013-63-561-2-xenogeneic-adipose-stem-cell-treatment-in-a-rat-model-of-peyronie-s-disease
#7
EDITORIAL
Fabio Castiglione, Petter Hedlund, Frank Van der Aa, Trinity J Bivalacqua, Patrizio Rigatti, Hein Van Poppel, Francesco Montorsi, Dirk De Ridder, Maarten Albersen
No abstract text is available yet for this article.
March 2013: European Urology
https://www.readbyqxmd.com/read/23259802/interview-immunogenicity-the-elephant-in-the-room-for-regenerative-medicine-interviewed-by-alexandra-hemsley
#8
Paul Fairchild
Paul Fairchild speaks to Alexandra Hemsley, Assistant Commissioning Editor Paul Fairchild began his research career in Oxford, UK, where he studied for a doctorate within the Nuffield Department of Surgical Sciences, focusing on the immune response to organ allografts. After spending 5 years as a postdoctoral fellow investigating the etiology of autoimmune disease in the Department of Pathology, University of Cambridge, UK, he returned to Oxford, where he is currently a University Lecturer in Preclinical Medicine within the Sir William Dunn School of Pathology and a Fellow of Trinity College...
January 2013: Regenerative Medicine
https://www.readbyqxmd.com/read/23040209/intratunical-injection-of-human-adipose-tissue-derived-stem-cells-prevents-fibrosis-and-is-associated-with-improved-erectile-function-in-a-rat-model-of-peyronie-s-disease
#9
Fabio Castiglione, Petter Hedlund, Frank Van der Aa, Trinity J Bivalacqua, Patrizio Rigatti, Hein Van Poppel, Francesco Montorsi, Dirk De Ridder, Maarten Albersen
BACKGROUND: Peyronie's disease (PD) is a connective tissue disorder of the tunica albuginea (TA). Currently, no gold standard has been developed for the treatment of the disease in its active phase. OBJECTIVE: To test the effects of a local injection of adipose tissue-derived stem cells (ADSCs) in the active phase of a rat model of PD on the subsequent development of fibrosis and elastosis of the TA and underlying erectile tissue. DESIGN, SETTING, AND PARTICIPANTS: A total of 27 male 12-wk-old Sprague-Dawley rats were divided in three equal groups and underwent injection of vehicle (sham), 0...
March 2013: European Urology
https://www.readbyqxmd.com/read/22974227/common-pitfalls-in-some-of-the-experimental-studies-in-erectile-function-and-dysfunction-a-consensus-article
#10
REVIEW
Selim Cellek, Trinity J Bivalacqua, Arthur L Burnett, Kanchan Chitaley, Ching-Shwun Lin
INTRODUCTION: Experimental studies investigating physiology of erectile function and pathophysiology erectile dysfunction employ several in vitro and in vivo techniques. As the field of sexual medicine expanding, the proper conduct of such techniques is becoming an even more important necessity than before. AIM: This review article aims to guide scientists, particularly young researchers and new comers in the field, toward employment of these techniques in an appropriate, timely, and competent fashion...
November 2012: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/22824778/emerging-tools-for-erectile-dysfunction-a-role-for-regenerative-medicine
#11
REVIEW
Lukman Hakim, Frank Van der Aa, Trinity J Bivalacqua, Petter Hedlund, Maarten Albersen
Erectile dysfunction (ED) is the most common sexual disorder reported by men to their health-care providers and the most investigated male sexual dysfunction. Currently, the treatment of ED focuses on 'symptomatic relief' of ED and, therefore, tends to provide temporary relief rather than providing a cure or reversing the cause. The identification of a large population of "difficult-to-treat" patients has triggered researchers to identify novel treatment approaches, which focus on cure and restoration of the underlying cause of ED...
September 2012: Nature Reviews. Urology
https://www.readbyqxmd.com/read/22300381/whole-genome-microarray-of-the-major-pelvic-ganglion-after-cavernous-nerve-injury-new-insights-into-molecular-profile-changes-after-nerve-injury
#12
COMPARATIVE STUDY
Giulia Calenda, Travis D Strong, Christian P Pavlovich, Edward M Schaeffer, Arthur L Burnett, Wayne Yu, Kelvin P Davies, Trinity J Bivalacqua
UNLABELLED: What's known on the subject? and What does the study add? With the present study, we aimed to provide a global picture of the molecular processes that are activated by CN injury. The present study used genomic expression profiling to identify candidate genes that might be useful targets in the CN recovery process and, thus, the ultimate preservation of penile erection. Regeneration of the CN and axonal outgrowth clearly involve changes in multiple biochemical pathways that have never been investigated by microarray analysis...
May 2012: BJU International
https://www.readbyqxmd.com/read/21056860/stem-cells-in-bone-grafting-trinity-allograft-with-stem-cells-and-collagen-beta-tricalcium-phosphate-with-concentrated-bone-marrow-aspirate
#13
REVIEW
Gregory P Guyton, Stuart D Miller
The orthopedic foot and ankle surgeon needs bone grafts in the clinical situation of fracture healing and in bone-fusion procedures. This article briefly outlines thought processes and techniques for 2 recent options for the surgeon. The Trinity product is a unique combination of allograft bone and allograft stem cells. The beta-tricalcium phosphate and collagen materials provide an excellent scaffold for bone growth; when combined with concentrated bone marrow aspirate, they also offer osteoconductive and osteoinductive as well as osteogenerative sources for new bone formation...
December 2010: Foot and Ankle Clinics
https://www.readbyqxmd.com/read/20621041/matrix-revolutions-a-trinity-of-defined-substrates-for-long-term-expansion-of-human-escs
#14
COMMENT
Samira M Azarin, Sean P Palecek
Recently in Nature Biotechnology, Rodin et al. (2010), Melkoumian et al. (2010), and Villa-Diaz et al. (2010) described defined, nonxenogenic substrates that support long-term self-renewal of human embryonic stem cells (hESCs). Used in conjunction with defined media, these substrates will facilitate expansion of hESCs for therapeutic applications.
July 2, 2010: Cell Stem Cell
https://www.readbyqxmd.com/read/20508016/trinity-evolution
#15
Shannon M Rush
Trinity Evolution Cryopreserved Cell Viable Bone Matrix is a minimally manipulated, human cellular, and tissue-based allograft containing adult mesenchymal stem cells, osteoprogenitor cells, and a demineralized cortical component. The cancellous bone used to produce Trinity Evolution is derived from freshly recovered donor tissue by Food and Drug Administration-registered facilities and processed under aseptic conditions. Preclinical in vivo and in vitro testing as well as strict donor screening has demonstrated the safety of Trinity Evolution as well as its osteoinductive and osteogenic potential contained within a natural osteoconductive matrix...
June 2010: Foot & Ankle Specialist
https://www.readbyqxmd.com/read/20508015/trinity-evolution-mesenchymal-stem-cell-allografting-in-foot-and-ankle-surgery
#16
Shannon M Rush
Biologic augmentation of orthopaedic procedures is a time-tested useful adjunct. The ability to predictably heal all fractures and arthrodesis procedures is still elusive because of multiple factors. The next frontier in musculoskeletal medicine and surgery will involve increasing biologic manipulation of the healing environment. Mesenchymal stem cell allograft is viable living biologic material that is capable of new bone formation and osteointegration at the implantation site.
June 2010: Foot & Ankle Specialist
https://www.readbyqxmd.com/read/19563195/-on-the-characteristics-of-acupoints-composed-by-trinity
#17
Jun-de Chen
In the present paper, the characteristics of acupoints in composition and their functional activities are discussed based on related domestic and abroad investigated results achieved in this area. Niche microenvironment of adult stem cells and correlative special differentiated cells are assembled, like gathering in caves, under the complex ation of network junctions of biological stress. A hypothesis of trinity is put forward to explain the construction and functional activities of acupoints.
June 2009: Zhongguo Zhen Jiu, Chinese Acupuncture & Moxibustion
https://www.readbyqxmd.com/read/18087639/endothelium-specific-gene-and-stem-cell-based-therapy-for-erectile-dysfunction
#18
REVIEW
Travis D Strong, Milena A Gebska, Arthur L Burnett, Hunter C Champion, Trinity J Bivalacqua
Erectile dysfunction (ED) commonly results from endothelial dysfunction of the systemic vasculature. Although phosphodiesterase type 5 (PDE-5) inhibitors are effective at treating most cases of ED, they must be taken routinely and are ineffectual for a meaningful number of men. In recent years gene and stem cell-based therapies targeted at the penile endothelium have been gaining momentum in preclinical studies. These early studies reveal that gene and stem cell-based therapies may be both enduring and efficacious, and may eventually lead to a cure for ED...
January 2008: Asian Journal of Andrology
https://www.readbyqxmd.com/read/17980035/the-drosophila-perlecan-gene-trol-regulates-multiple-signaling-pathways-in-different-developmental-contexts
#19
Jonathan R Lindner, Paul R Hillman, Andrea L Barrett, Megan C Jackson, Trinity L Perry, Youngji Park, Sumana Datta
BACKGROUND: Heparan sulfate proteoglycans modulate signaling by a variety of growth factors. The mammalian proteoglycan Perlecan binds and regulates signaling by Sonic Hedgehog, Fibroblast Growth Factors (FGFs), Vascular Endothelial Growth Factor (VEGF) and Platelet Derived Growth Factor (PDGF), among others, in contexts ranging from angiogenesis and cardiovascular development to cancer progression. The Drosophila Perlecan homolog trol has been shown to regulate the activity of Hedgehog and Branchless (an FGF homolog) to control the onset of stem cell proliferation in the developing brain during first instar...
2007: BMC Developmental Biology
https://www.readbyqxmd.com/read/17071732/mesenchymal-stem-cells-alone-or-ex-vivo-gene-modified-with-endothelial-nitric-oxide-synthase-reverse-age-associated-erectile-dysfunction
#20
Trinity J Bivalacqua, Weiwen Deng, Muammer Kendirci, Mustafa F Usta, Christine Robinson, Bradley K Taylor, Subramanyam N Murthy, Hunter C Champion, Wayne J G Hellstrom, Philip J Kadowitz
Mesenchymal stem cells (MSCs) can be used in adult stem cell-based gene therapy for vascular diseases. To test the hypothesis that MSCs alone or endothelial nitric oxide synthase (eNOS)-modified MSCs can be used for treatment of erectile dysfunction (ED), syngeneic rat MSCs (rMSCs) were isolated, ex vivo expanded, transduced with adenovirus containing eNOS, and injected into the penis of aged rats. Histological analysis demonstrated that rMSCs survived for at least 21 days in corporal tissue after intracavernous injection, and an inflammatory response was not induced...
March 2007: American Journal of Physiology. Heart and Circulatory Physiology
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