What You Will Learn!
- Find and interpret information from publicly available sources and make better treatment decisions.
- Appreciate the unique characteristics of different types of stem cells and their typical use in research and therapy.
- Understand the difference between research and therapy
- Find and interpret relevant information on stem cell research in two main clinical research registries - ClinicalTrials.gov and ICTRP
- Export/download and collate data from trial registries, and interpret the findings in context of other sources such as scientific libraries and regulatory data.
- Locate and assess relevant information in other sources, such as the NIH registry and the FDA registry.
- Find relevant published literature in PubMed and interpret the findings.
- Relate to patient motivations to seek unproven stem cell therapies off shore.
- Understand the main guiding principles of stem cells research and therapies in the U.S. and in Europe.
- Cite the most relevant regulations and guidelines governing stem cell research and therapies in the U.S. and in Europe, and explain the nature and history of controversies and restrictions relating to embryonic stem cells.
- Understand the nature of changes of regulatory environment in China.
- Understand the role of professional societies in the regulation and self-regulation of stem cell research and therapies.
Description
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
POTENTIAL: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
CLASSIFICATION: Origin and ability of stem cells to differentiate into different cell types determines how different types of stem cells are typically used.
CLINICAL RESEARCH: In this section, we will introduce two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real time interactive sessions are included to allow students to ask questions and offer additional guidance.
PATIENT DEMAND: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies and patient autonomy.
REGULATORY AND LEGAL FRAMEWORK: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for their stem cell clinics, regulating both trials and treatments.
PROFESSIONAL SOCIETIES: The last section explains the role of professional societies in stem cell research and therapies.
Who Should Attend!
- The course on Stem Cell Research and Therapies is intended for patients and their families and friends who need to find more information about stem cells, who wish to learn how to find relevant information online, and how to work with publicly available resources such as databases and registries, to be able to make informed decisions for themselves.
- The course can also be useful as a primer for those who need to learn the essentials about stem cells as part of their professional training.
- The course i not intended for medical professionals whose understanding of the topic is generally more advanced.
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