Chairs
Dr Sheila MacNeil, University of Sheffield
Dr Sheila MacNeil, University of Sheffield
Sheila is Professor of Tissue Engineering at Sheffield University ( non-clinical) with expertise in tissue engineering of skin, oral mucosa, urethra, oesophagus and cornea with a strong focus on translating research to the clinic. She has published over 350 peer-reviewed articles with over 7000 citations and has an h-index of 45. Since 1992 she has worked with clinicians in Sheffield, delivering autologous keratinocytes to burns patients and developed and commercialised improved delivery of skin cells to patients with MySkin™ and Cryoskin™ (autologous and allogeneic cell therapy for wound healing), available for NHS patients via Regenerys Ltd (www.regenerys.com). She has also worked extensively with NHS Urologist Professor Chris Chapple in Sheffield to develop tissue engineered oral mucosa for reconstruction of urethral stricture and published a 9 year follow-up on this recently. Another key project is developing cell delivery membranes for corneal defects (Wellcome Trust Affordable Healthcare for India) working with colleagues in India. She has also been developing an alternative material for support of the urethra with Professor Chris Chapple over the last 6 years which will better withstand the dynamic pressures in the pelvic floor.
She received the UK Society of Biomaterials President’s medal for her contributions to Biomaterials in both the UK and overseas in September 2014.
13:30-14:00
Non-cellular regenerative medicine techniques for prevention of female pelvic floor disorders
Professor Margot Damaser, Cleveland Clinic Foundation
Abstract
One of the greatest risk factors for development of pelvic floor disorders is vaginal delivery of children, which can damage the nerves and muscles responsible for continence in addition to the connective tissues responsible for the position of pelvic organs. Without complete nerve regeneration, the muscles can atrophy. Pelvic floor connective tissue can fail to restore the vascularisation necessary for full regeneration. Current treatments, such as an implanted mesh or sling, can have a high rate of complications and a high revision rate. Regenerative interventions done soon after delivery of children, prior to muscle atrophy, has the potential to have an increased success rate and to prevent pelvic floor disorders.
Regenerative medicine usually involves local treatment with autologous stem or progenitor cells. This approach has had mixed results in clinical trials with women with stress incontinence. The mechanism of action of these cells is likely via their secretions. Therefore, a non-cellular approach with fewer risks could be to give the secretions of stem cells rather than inject the cells themselves. This approach also holds the promise of providing an off-the-shelf treatment.
This talk will summarise our preclinical studies which demonstrate that treatment with secretions of cells provide a strong regenerative effect, even when given systemically. In addition, Professor Damaser will present preclinical data demonstrating that electrical stimulation could also promote neuro-regeneration and facilitate repair. Non-cellular therapies, such as these, given soon after childbirth in women at greatest risk of development of pelvic floor disorders hold great potential to improve the lives of many women.
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Professor Margot Damaser, Cleveland Clinic Foundation
Professor Margot Damaser, Cleveland Clinic Foundation
Dr Damaser received her PhD in Bioengineering from the joint program of the University of California San Francisco and Berkeley. She is currently Professor of Molecular Medicine in the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and has joint appointments in the Biomedical Engineering Department and the Glickman Urological and Kidney Institute at Cleveland Clinic. She also is a Senior Research Career Scientist in the Advanced Platform Technology Center of Excellence of the Louis Stokes Cleveland VA Medical Center, Cleveland, OH. She has conducted research on the causes of and treatments for female pelvic floor disorders for over 20 years. She has developed and used animal models to test novel therapies with a focus on applying techniques from regenerative medicine to pelvic floor disorders. Dr Damaser has over 130 scientific peer-reviewed publications, has a number of patents pending, and has had research grants from NIH, US Dept of Veterans Affairs, private foundations, and several companies.
14:00-14:30
Preclinical animal models for pelvic organ prolapse
Professor Jan Deprest, UZ Leuven
Abstract
The cause of pelvic organ prolapse (POP) is multifactorial yet includes a complex interplay between genetic factors, vaginal birth-induced trauma, aging and lifestyle. Currently, surgery is the mainstay of therapy and the life-time risk is 19% by the age of 802. Given the relevance of the condition and the failure of current strategies a better understanding of the genesis of POP and the potential for its prevention or improving current therapies appropriate animal models are required. Finding an optimal model is challenging, since humans are bipedal, have no tail, and the foetal head is relatively large compared to the pelvic dimensions, making vaginal delivery more traumatic when compared to other species. This talk will discuss both pelvic organ prolapse and birth induced injuries in animal models
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Professor Jan Deprest, UZ Leuven
Professor Jan Deprest, UZ Leuven
Jan Deprest MD PhD FRCOG is Professor of Obstetrics and Gynaecology at the Faculty of Medicine (KU Leuven) and its University Hospitals Leuven and at University College London. He is the Academic Chair (2012-2021) of the Department of Development and Regeneration, under which Obstetrics and Gynaecology is resorting. He is the Director of the Training Center for Surgical Technologies, with Prof Paul Herijgers. He is member of the Group Board of Biomedical Sciences KU Leuven (2014-2017).
In Leuven, he is the clinical director of the fetal therapy program as well as the co-director of program for female pelvic floor dysfunction. He is also a member of the staff of Gynaecology.
His research is mainly translational and dedicated to surgical treatment options as well as cell therapy solutions for (prevention of) pelvic floor dysfunction. His clinical research into urogynaecology is focused on the use of imaging, outcomes of implant surgery and surgical treatment of level I defects.
He published over 470 peer reviewed papers and supervises/d over 25 doctoral students.
He is Editor of Prenatal Diagnosis (Section: Fetal Imaging and Therapy), Editor in Chief Gynaecologic
Surgery (2013), and International Editorial Board member of BJOG. He is board member of the national society of Obstetrics and Gynaecology (V.V.O.G) where he is chairing the scientific committee. He serves on the scientific committee of ESGE and EUGA
15:20-15:45
Safety and performance of a wireless implantable tibial nerve stimulator device, for the treatment of patients with overactive bladder (OAB)
Dr Guri Oron, BlueWind Medical
Abstract
Overactive bladder (OAB) affects millions of people worldwide with neuromodulation offering treatment option for refractory patients. A novel peripheral implantable neurostimulator device for the treatment of OAB was developed (RENOVA iStim™ system), which electrically stimulates the tibial nerve at the site just proximally of the medial malleolus. The implant is wirelessly powered by a wearable unit that controls the therapeutic parameters and is worn by the patient during treatment at home. A Clinician Programmer is used to remotely set individual stimulation parameters. Herewith, the safety and performance of the RENOVA iStim™ system is being observed for the treatment of OAB. Short term; 6-mos results, and long term; 24-mos partial results, will be presented.
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Dr Guri Oron, BlueWind Medical
Dr Guri Oron, BlueWind Medical
Dr Guri Oron has co-founded Bluewind and been with the company since its inception. He has over 15 years of experience in executive R&D roles, primarily with startups in the medical device field with specific expertise in Neurostimulation technologies. Throughout his career Dr Oron managed complex R&D projects from their ideation through design, engineering, regulatory and clinical development. Prior to working with BlueWind Medical, led the R&D at BrainsGate and before that in defence R&D roles. Dr Oron holds a BSc in Electrical Engineering from Tel Aviv University. He is the lead inventor or co-inventor of numerous patent and patent pending applications.
15:45-16:10
Mechanical and etiological aspects of female pelvic floor disorders
Dr Pedro Martins, University of Porto
Abstract
It is commonly accepted that Pelvic floor disorders (PFD) have many risk factors. However, there is no consensus on their scope and importance. Some are specific for an individual (number of pregnancies) others common to a group or population. A complete and coherent map of prolapse etiology remains an open question.
The complexity of PFD led to different, often complementary, research efforts. The mechanical behaviour of pelvic tissues, is intimately linked with their ‘normal’ and ‘diseased’ status; also influenced by individual characteristics (age, hormonal status, etc.). This led to studies on the changes in the morphology and biomechanics of pelvic tissues using animal models, since it is not feasible (materially, ethically, etc.) to conduct some research on humans. These studies are designed to clarify the scope of each PFD risk factor.
A new and promising frontier lies on the fusion of statistical/epidemiologic information with individual-level knowledge. The estimation of tissue’s mechanical behaviour based on patient specific data, may in turn, feed epidemiologic models with predictive capabilities. Such models bring an array of possibilities and implications - improved clinical diagnostics, PFD risk assessment, improved surgical outcome estimation, etc. To build such tool(s) will require a multidisciplinary effort, between medical doctors, engineers, and mathematicians.
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Dr Pedro Martins, University of Porto
Dr Pedro Martins, University of Porto
Pedro Martins is a Postdoctoral researcher (INEGI, FEUP) and Invited Assistant Professor, in the department of Mechanical Engineering at the Faculty of Engineering of Porto University (FEUP, Portugal). Pedro completed his Ph.D. in Mechanical Engineering with application to biomechanics, at FEUP. His undergraduate studies, in theoretical physics, were developed at the Faculty of Sciences of Porto University (FCUP). His research has been focused on the mechanical properties of biological tissues and biomaterials. He has studied the female pelvic floor tissues, under normal and pathological conditions. He has collaborated with several researchers, on multidisciplinary research projects, on domains that range from applied mechanics to image processing. He his author and co-author of more than 40 research papers, was awarded 3 individual merit fellowships and has is the PI of 3 research projects in the field of Biomechanics.
16:10-16:40
Tissue engineering and regeneration: regulatory routes to the clinic
Ms Alison Wilson, CellData Services
Abstract
Developing a new medical product requires an understanding of the regulatory environment: how the law views the product and which agencies must be involved in the process. This talk will highlight the different ways in which regenerative medicine products can be regulated in the UK/EU, which in turn dictates how they can be brought into clinical use. Authorisation for clinical trials, processes and supporting data requirements are all entirely dependent upon how a TE/RM product is regulated: as a medical device, a human tissue product or a medicinal product / ATMP. Although perhaps not as exciting as the scientific and clinical challenges involved, an appreciation of the regulatory position early in the process can only increase your chances of successfully developing a safe, effective product that reaches patients in a timely way.
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Ms Alison Wilson, CellData Services
Ms Alison Wilson, CellData Services
Alison Wilson is an independent regulatory affairs consultant with over 25 years’ experience in medicinal products, cell-based therapies and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 - Tissue Engineered Medical Products, and a member of the British Standards Institute Regenerative Medicine Technical Panel. Alison is a Module Advisor for the TOPRA MSc in Regulatory Affairs. She has contributed to several BSI cell therapy publications and has several publications on regulation of regenerative medicine products.
Alison provides strategic regulatory and development advice for companies developing commercialise advanced therapy medicinal products (ATMPs) and regenerative medicine therapies in the EU. Alison is a Fellow of TOPRA and in 2014 received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.