Day 2 :
- Cancer Cell Biology | Advancement in Cancer Treatments
Session Introduction
Magdalene Karon
Dr. Karon’s Pelvic Reconstructive Surgery and Research Center, Lexington, KY
Title: Regenerative healing as it applies to gynecologic surgery using mesenchymal stem of placental/amniotic origin
Biography:
Magdalene Karon MD is an OB/GYN, urogynecology specialist in clinical practice for 31 years in Lexington, Kentucky, USA. In addition to a high-volume surgical experience, she continues to practice obstetrics with added interested in banking birth tissue. She is known for her experience in Robotic Laparoscopic surgery and is one of the busiest robotic surgeons in her region, where she has performed over 2000 cases. Her clinical research has focused (since 2012) on developing a biologic patch as an alternative to the synthetic mesh in pelvic reconstruction. Dr. Karon is a recent recipient of the Surgeon of Excellence in Robotic Surgery accreditation. She has been listed as one of America's top Obstetricians and Gynecologists by Consumer's Research Council of America since 2011. She is a member of the American Medical Association (AMA), Kentucky Medical Association (KMA), American Urogynecology Society (AUGS) and a board-certified fellow of The American College of Obstetrics and Gynecologists (ACOG).
Abstract:
Ten applications in gynecologic surgery and one in obstetrics will be presented.
The unique biologic structure and components of the placental tissue coupled with the immune privileged response provide an ideal choice for homologous clinical use. The pluripotent mesenchymal cells in the presence of an acellular matrix (scaffold) have the capability to start the regenerative process in any tissue they are placed next to. With the addition of growth factors and mediators also present in the placental/amniotic tissue, reconstruction begins. The process is quite different than healing by scar tissue formation and foreign body reaction such as happens with synthetic meshes and other devices. TGF-β and its receptor expression by fibroblasts promote reconstruction rather than scar and adhesion formation. Ani microbial properties, angiogenesis and interleukin-1 receptor antagonist which modulate pain secondary to inflammation are additional advantages.
The use of human cells, tissue and cellular/tissue-based products are considered “on the label” by the FDA according to the Regulatory Guidance issued by them in November 2017, as long as we follow homologous use and minimal manipulation.
Other specialties such as orthopedics, ophthalmology, and wound care centers have adopted the use of placental/amniotic tissue to complement healing. We present here the first applications in Ob/Gyn.
We will show intraoperative pictures from laparoscopic robotically assisted surgeries such as sacrocolpopexy and para vaginal defect repair for pelvic prolapse using biologic matrix patch. Also, robotic laparoscopic myomectomy using viable cryopreserved umbilical tissue. We will present how amniotic fluid allograft injected into an ovary after endometrioma resection can raise the Anti- Mullerian Hormone by 167%. Pudendal block for neuralgia, fistula repair and other applications will follow.
Gary Hin-Fai Yam
Singapore Eye Research Institute, Singapore
Title: Cultivated corneal stromal cell therapy for corneal opacities
Biography:
Abstract:
Corneal opacities/scar is a significant cause of global blindness. In most situations, surgical removal can restore eyesight, however the accessibility to modern day surgery is restricted worldwide, due to donor material shortage, lack of surgical expertise, graft rejection and immune responses. Hence, there is a need to develop new strategy to restore corneal clarity and visual functions. The purpose of this study is to evaluate the safety and feasibility of intrastromal injection of cultivated human corneal stromal keratocytes (CSK) and its therapeutic effect on a rat early corneal opacity model. Primary human CSK were propagated under ERI protocol1. Some CSK were converted to stromal fibroblasts (SF) in serum culture. They were intrastromally injected to rat normal corneas or corneas with early opacities induced by irregular phototherapeutic keratectomy, followed by the examination of corneal response under slit lamp biomicroscopy and in vivo confocal microscopy with the evaluation of corneal haze level and stromal reflectivity, and corneal thickness using anterior segment optical coherence tomography. Corneas with CSK injection showed proper expression of human keratan sulfate proteoglycans (KSPG: lumican, keratocan, ALDH3A1) with negligible inflammation, hence maintaining corneal clarity and stability. The progressive loss of injected cells over time was recovered by repeated injection, achieving an extended expression of human KSPG inside rat stroma. SF injection, on the other hand, induced corneal haze and thicker corneas. In early corneal opacity model, cultivated CSK injection reduced the stromal reflectivity and corneal thickness, resulting in a recovery of corneal clarity, whereas non-injected corneas were thicker and had haze progression. Our results demonstrated the safety, feasibility and therapeutic efficacy of intrastromal CSK injection. The cultivated CSK can be a reliable cell source for a potential cell-based therapy for patients with corneal opacities and stromal disorders.
Marco Fadda
Comecer spa, Castel Bolognese, Italy
Title: The use of improved traditional GMP manufacturing techniques contributes to the success of Large Scale State-of-the-Art production of EMA-approved Cartilage Substitute.
Biography:
Marco Fadda, Biomed. Eng., began as researcher in a biomechanics laboratory, investigating bone cutting quality using robot held tools, followed by development of medical robotics, together with customer training and OR support. Successively, served as executive for top brands in the Medical Device Industry, with focus to understanding medical needs and transforming them into successful and remunerative global surgical solutions. Since 2014 he is dedicated to the development of principles and solutions for managing cell manipulation, expansion and transformation in aseptic environments. Main goal is the application of principles of Isolation Technology to ATMP development and production, with integration of all the necessary process tools and devices into a Grade A environment. The final aim is to perform GMP research and production of ATMPs, under full Isolation Technology, to simplify the production processes and to automate them as much as possible, aiming at a final reduction of the COGS, for a wider acceptance and a larger possibility of use of these products.
Abstract:
Recent progresses in several different fields of Advanced Therapies manufacturing showed an increasing demand for new, enhanced, effective processing and expansion methods. Main goals of this renewed effort aim at reducing the impact of the COGS in the development, adoption and finally commercialization of ATMPs.
Moreover, discovery and clinical proof of different, improved treating methods for certain diseases, opens demand for having available high quantities of a given product, impacting on and challenging the production capacity for suitable and successful scale-up.
A significant example, relies in the case described here. We report a successful ATMP treatment for Cartilage defect (Spherox, Co.don AG), which was approved by EMA on 2017, putting emphasis on the current manufacturing technology.
The approach described here, while not changing the process as initially developed and approved by the regulatory authorities for low-scale production, addresses the issues above, boosting the production capabilities in a brand-new full GMP-compliant designed plant. Key points are the use of isolation technology, together with a new modular and flexible approach for safe incubation of a large number of individual batches. This approach has been coupled with an accurate matching between the low- and large-scale process steps, a significant level of process automation (both in worklist and patient material management) and finally, a complete top-class track & trace software control and management system. Under these premises, the plant will be able to deliver the required doses of the ATMP drug (several thousand patients per year), under full respect of all the quality issues and in total compliance with all the regulatory rules
- Stem Cells and its Applications | Biomaterial and Bioengineering | Biobanking
Session Introduction
Suchi
Chair, Global Goodwill Ambassadors (GGA)
Title: Adopting laughter therapy to get dosage of happy hormones to remove stress caused by being in slight pain ,being depressed, being unhappy anxious or sad. Saying positive affirmations aloud changes body cell energy.
Biography:
MS. SUCHI is an experienced International Pre School Principal/Manager who picked up Laughter exercises from many coaches around the world. She then designed ‘Laughter Therapy' which is being used in many places such as hospitals and Senior Activity Centres. She provides individual and group therapy in educational and home settings.
A former Manager / Trainer is now engaging in building social awareness about Holistic approach for recovery. Be it Depression, Anxiety caused by physical or emotional pain, Death in the family and the harm the unhappiness brings to people, families and communities. Her aim is to encourage people to seek help early and get on the path to recovery. Her works has been featured in local press, TV and Radio and has been an invited speaker at various community clubs and educational Institutions. She has also been awarded by MINDS and various community clubs in recognition of her social work.
Abstract:
Statement of the Problem:
There is a lack of awareness about what happy hormones are ,how to use positive words to feel energetic and what can be done to get happy hormones. People tend to feel unhappy for multiple reasons and neuropathic pain adds on Stress levels of not only the patient but the caregivers as well. Being in pain leads to feeling depressed and anxious in some cases.
Methodology & Theoretical Orientation:
Review of Books and Research shows that getting a dosage of happy hormones will not only ease slight pain of the patient but feeling happy will also have a positive impact on the recovery of the patient. Adopting Laughter therapy and getting hormones which makes one feel good will help many to recover from Neuropathic pain /Long term sadness caused by having grief ,Anger or Resentment, Depression & Anxiety.
Findings:
One needs to work on his/her energies using Laughter Therapy which is a positive approach for not having Depression & Anxiety caused by Neuropathic pain. The therapy can be used as a Holistic way to recovery.
Conclusion & Significance:
The Laughter therapy which includes ways to get the dosage of happy hormones promotes overcoming Depression & Anxiety caused by Neuropathic pain, is a fun way to manage pain. Repeated sessions to be conducted to remind patients that life while having pain or during the recovery should go beyond just seeking medical and counselling help and also include rebuilding Spiritual, Physical, Emotional, Relational and Mental health. The model has been put together from for testing in many settings including hospitals, elderly homes and senior citizen centres. This is not a research book or paper. It is just an effort to demystify the help available for Depression & Anxiety caused by pain. It is an attempt to motivate and encourage people to seek help and take a simple approach to remember and work on all aspects of their recovery.
Hso-Chi Chaung
National Pingtung University of Science and Technology, Taiwan
Title: Co-culture of T subsets and antigen-presenting cells to form immune synapse
Biography:
Abstract:
The importance of the interactions of pathogens and the immune system has played a extremely important role in agricultural research for development of vaccinations. Porcine reproductive and respiratory syndrome (PRRSV) causes severe economic loss to the swine industry worldwide. The aim of this study is to establish a immune synapse system by co-culturing T subset/antigen-presenting cell as a fast screening system. In this study, blood samples were collected from 12 SPF pigs that were randomly separated into 3 groups for the control group and two different vaccinated immunizing PRRSV subunit vaccines (PRRSV-1 and PRRSV-2). Different T subsets by fluorescence-activated cell sorting were co-cultured with alveolar macrophage and the profiles of cytokine secretion and mRNA transcription levels of toll-like receptors were examined. The results showed that there were significant interaction differences in IL2, TLR3, TLR8, and TLR9 expressions between vaccinated groups and co-cultured cell systems. For instance, TLR8 expressions in CD4+CD25+ cells of PRRSV-2 (1.005±0.865) were lower than those in same cell system of controls (2.625±1.552). Interesting, the significantly lower IL-10 production were observed in animals vaccinated with PRRSV-2 (1.459± 0.396) as compared with those in control (4.155±1.494) or vaccinated with PRRSV-1 (4.781±1.135). These findings demonstrated that a porcine immune synapse system can be potentially used as screening the micro-environment factors as the adjuvant candidate or effective antigen epitopes. This system will be beneficial in reducing the use of experimental animals when studying the immune system whilst developing disease-resistance biomarkers or immune-modulatory adjuvants.