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SELECTBIO Conferences Translational Regenerative Medicine Congress 2014

Translational Regenerative Medicine Congress 2014 Agenda

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Tuesday, 21 October 2014



Session: Regulatory Environment and Bench to Bedside Process in Regenerative Medicine
Session SponsorsSession Sponsor


Welcome and Introduction
Frank Emmrich, Director, TRM Leipzig, Germany


Bench to Bedside Successes at the TRM Leipzig
Ulrich Sack, Associate Director of Research, TRM Leipzig, Germany

Translation of Regenerative Medicine from bench to bedside depends on customized support to young scientists. Prototypic examples of translational processes from the TRM Leipzig will be presented.


Regulatory Pathways to the Market
Timo Faltus, Investigator, TRM Leipzig, Germany

The presentation illustrates the legal gateways to the European market for (stem) cell based products from (basic) research to market approval.


Successful GxP Practice
Dirk Sawitzky, Quality Manager Non Clinical Test Facility, Universität Leipzig, Germany

The pharmaceutical industry of the European Union maintains high standards of Quality Management in the development, manufacture and control of medicinal products. This is ensured by the principles of “GxP” for “Good Laboratory, Clinical, Manufacturing and Distribution Practice”.


Coffee and Networking in Exhibition Hall

Session: Eye and Legal Application Permission of Innovative Treatments
Chair: Christian Koch


Conor RamsdenKeynote Presentation

Stem Cells in Retinal Regeneration
Conor Ramsden, Clinical Research Fellow, Institute of Ophthalmology, University College London, United Kingdom

Experimental to clinical transplantation of pluripotent stem cells for cell therapy in retinal disease.


Scleral Crosslinking by an Innovative Substance and Irradiation System - A Novel Medical Device for a New Therapeutic Approach
Mike Francke, Investigator, TRM Leipzig, Germany

Scleral collagen crosslinking as a suggested therapeutic approach in ophthalmology induces remodelling processes in scleral tissue. Application of riboflavin and blue light leads to activation of fibroblasts and induces remodelling of the collagen fibril and bundle structures.


Biomaterials Enhanced Regeneration of the Human Cornea
May Griffith, Professor, Linkoping University, Sweden

Biomimetic materials mimicking the extracellular matrix of the human corneal stroma promote stable regeneration of the human cornea. Addition of a second network of polymers to the implants further reinforced the materials to allow for integration into high risk corneas.


Marketing Authorisation Procedure for ATMPs
Matthias Wilken, Head of Drug Regulatory Affairs Europe / Scientific Aspects in Social Law, German Pharmaceutical Industry Association, Germany

The talk is about the legal requirements concerning marketing authorisation procedures in Europe for advanced therapy medicinal products. Beside the centralised marketing authorisation, the certification procedure, the classification procedure and the so-called hospital exemption clause are addressed.


Lunch and Networking in Exhibition Hall

Session: Bone, Cartilage & Muscle
Chair: Christoph Josten


Establishing of a Stem Cell Based Articular Cartilage Graft
Ronny Schulz, Investigator, TRM Leipzig, Germany

The successful development of an advanced therapy medicinal product (ATMP) made of mesenchymal stem cells (MSCs) for the treatment of articular cartilage based on actual EU regulations and clinical recommendations lie within the realm.


Potential of Autologous 3D Adipose Stem Cells Graft for Bone Reconstruction
Denis Dufrane, Professor, Catholic University of Louvain, Belgium

The transformation of autologous adipose stem cells in a 3-dimensional osteogenic graft can open a new way for surgical reconstruction of large bone defect (after tumour resection and pseudarthrosis) with minimal invasive procedure.


Ethical Challenges in Translating ATMPs for Orthopedic Disorders into Clinical Trials and Society
Sophie Niemansburg, PhD Student, University Medical Center Utrecht, Netherlands

In this presentation I will discuss the results of an empirical study on the attitudes, opinions and expectations of biomedical professionals, mainly basic scientists and surgeons, on the ethical issues of translating ATMPs for orthopedic disorders into (early) clinical studies and society.


Genetic Stability and Tumorigenicity within Chondrocyte Cultures using GTG, SKY and Locus-specific FISH
Heidrun Holland, Investigator, TRM Leipzig, Germany

The development of cell-based therapy for clinical studies raises the question whether the application of cell-based products to humans is safe. Therefore, different genetic analyses were performed to show the presence or absence of genetic instabilities.


Coffee and Networking in Exhibition Hall

Session: Clincal Video Tutorial with Planned Life Annotations


Clinical Video Tutorial with Life Annoation
Enal Razvi, Managing Director, Select Biosciences Inc, United States of America

The Clinical Video Tutorial was shot at the SELECTBIO Clinical Translation of Stem Cells Conference, April 21-22, 2014, Palm Desert, California, USA. This practicum was conducted by a number of clinicians who are all board-certified in the United States. The key clinicians performing the adipose tissue harvest were Joseph Purita, MD, and Allan Wu, MD, and this was performed at the La Quinta Surgery Center, Palm Desert. The clinical practicum was designed to demonstrate adipose tissue (fat) harvest procedure in a clinical setting from a patient who had given informed consent for us to videotape this procedure. Subsequent to the fat harvest, we present some of the ex vivo procedures that were performed on the fat, namely the isolation of adipose-derived stem cells. These cells were subsequently injected back into the patient with minimal ex vivo manipulation and no ex vivo culture. The goal of this practicum is to illustrate the methodologies, procedures, and type of environment wherein adipose tissue (fat) extraction takes place and its deployment in regenerative medicine.

Wednesday, 22 October 2014



Session: Skin and Blood Vessels
Chair: Timo Faltus
Session SponsorsSession Sponsor


Heike WallesKeynote Presentation

Engineering of Complex 3-D-Tissues
Heike Walles, Chair/Head, University Hospital of Wuerzburg, Germany

The development of vascularized tissues, as trachea, bone, skin etc based on decellularized porcine small bowl segments (BioVaSc) will be shown. During the talk the application of complex 3D tissues as alternative for animal models and implants will be discussed.


Melanocytes from Hair Follicles for Vitiligo Treatment
Vuk Savkovic, Investigator, University of Leipzig, Germany

We are working on developing melanocytes and keratinocytes from a novel source of stem cells  with utmost high developmental potency - the outer root sheath (ORS) of hair follicle - for purposes of regenerative therapy of Vitiligo and wound healing.


MSCs for Vascular Regeneration and Wound Healing
Thomas Ritter, Senior Lecturer, National University of Ireland, Ireland

Data will be presented on the use of MSCs in pre-clinical models of skin ulcer and critical limb ischemia (CLI). Based on pre-clinical efficacy and toxicity data we have received a manufacturing license and clinical trial authorization for a CLI study in Ireland.


Stem Cells in the Treatment of Peripheral Arterial Diseases. Clinical Results and New Frontiers
Alessandro Schiavetta, Main Investigator, Head, Innovative Therapies Unit, Ospedale Santa Corona , Italy

NAPLES Study ended in 2012 and tested the use of stem cells in the treatment of patients affected by arterial diseases and critical limb ischemia. Angiogenetic therapies have shown to be promising and allow an increase of amputation-free survival of patients. And new frontiers are in front of us.


Coffee and Networking in Exhibition Hall

Session: Blood and Cord Blood
Chair: Susanne Muller


Select Biosciences IncTechnology Spotlight:
Qualitative and Quantitative Analysis of the Worldwide Cord Blood Marketplace
Enal Razvi, Managing Director, Select Biosciences Inc

This presentation provides a qualitative and quantitative analysis of the cord blood marketplace, circa 2014, describing the trends in this space, and challenges for cord blood banking to remain a sustainable business opportunity.


Regeneration of Normal Hematopoiesis: Prevention of Immunological Complications with Preserved Anti-tumor Effect Following Hematopoietic Stem Cell Transplantation
Stephan Fricke, Investigator, Fraunhofer Institute for Cell Therapy and Immunology IZI, Germany

The development of new immunological therapies for separation of graft-versus-host-disease from the anti-tumor effect after allogeneic hematopoietic stem cell transplantation without the need of conventional immunosuppressive drugs will be demonstrated.


Cord Blood and Cord Tissue-derived Stem Cells: Bringing Transplants to the Patients
Sanja Pavlica, Scientific Associate Production, VITA 34 AG, Germany

Herein we describe the requirements to bring the stem cells, isolated from the umbilical cord blood and tissue, to the patients enabling their clinical utility.


Cord Blood Stem Cells: Current Uses and Future Applications in Regenerative Medicine
Mathias Freund, Professor/Director, Seracell Pharma, Germany

The presentation will give an insight into the current status of autologous and allogeneic hematopoietic cord blood transplantation as well as present studies on immune modulating and regenerative applications. The perspective of regenerative medicine and organ replacement is discussed.


Lunch and Networking in Exhibition Hall

Session: Stem Cell Sources and Reimbursement
Chair: Hans Jorg Meisel


Lukas PrantlKeynote Presentation

Efficacy and Safety of Fat Stem Cell Therapy in Breast Surgery
Lukas Prantl, Professor/Head, University of Regensburg, Germany

We will report our clinical experience involving 500 patients with adipose tissue transplantation and discuss the regenerative potential of adipose stem cells.


Adipose Derived Stroma/Stem Cells and Angiogenesis: From Bench to the Bedside and How We Can Move On
Louis Casteilla, Director STROMALab, University of Toulouse, France

Adipose-derived stroma/stem cells (ASC), that can be easily obtained from fat, display great angiogenic properties that are now tested at clinical level. These features are strongly controlled by redox metabolism and manipulating oxidative stress is a mean to counteract against ageing effects.


Reimbursement for ATMPs in Germany - Prospective for Europe
Matthias Perleth, Department Head Methodological Advice, Federal Joint Committee, Germany

This presentation will focus on reimbursement of ATMPs in Germany with a glance at the European developments. Requirements for regulatory and coverage decisions will be addressed and some examples will be used to illustrate these issues.


Coffee and Networking in Exhibition Hall

Session: Liver and Pancreas
Chair: Bruno Christ


Stephen StromKeynote Presentation

Skype Presentation - Human Hepatocyte Transplantation
Stephen Strom, Professor, Karolinska Institute, Sweden

Hepatocyte transplantation has been an alternative to whole organ transplantation for 20 years, yet the numbers of patients receiving this treatment is relatively small. This presentation will discuss the application, methods, problems and possible solutions to increase the efficacy of hepatocyte transplantation.


Hematopoietic Stem Cells and Derived Microparticles in Liver Regeneration
Moritz Schmelzle, Investigator, TRM Leipzig, Germany

Hematopoietic stem cells (HSC) are mobilized from the bone marrow in response to acute liver injury and boost liver regeneration. Rapidly shed HSC-derived plasma microparticles may serve as novel biomarkers in liver disease with therapeutical implications.


MSC Transplantation in Postoperative Liver Failure (POLF)
Hans-Michael Tautenhahn, Invesitgator, TRM Leipzig, Germany

After extended liver resection, postoperative liver failure (POLF) is a serious problem with high mortality. Mesenchymal stem cells (MSC) improved liver regeneration by decreasing apoptosis and increasing proliferation of hepatocytes in the residual liver.


End of Conference

Add to Calendar ▼2014-10-21 00:00:002014-10-22 00:00:00Europe/LondonTranslational Regenerative Medicine Congress 2014Translational Regenerative Medicine Congress 2014 in Leipzig, Germany Leipzig, Germany