Regenerative and Stem Cell Technologies Degree Details and Courses

This course will explore the cellular and molecular mechanisms involved in the growth and development of complex organisms. In particular, students will be introduced to the mechanisms of fertilization, formation of the early body plan, cell type determination, organogenesis, morphogenesis, and stem cell niches. The course will examine the cellular and morphological changes during development, as well as the molecular signals responsible for development of organisms.

In this course, students learn about how gene therapy can be used to treat or prevent genetic disease in the human population. This course is centered around how disease-causing variations in the human genome, including inherited diseases, mutations, epigenetic modifications, and viral infections, can be targeted using molecular technologies. Students will learn about the benefits and limitations of gene therapy and the bioethical concerns involved with this field of research and medicine. Prerequisites: 410.603 Advanced Cell Biology or equivalent.

Regenerative Medicine is a multidisciplinary field developing next-generation therapies that aim to augment, repair, replace or regenerate tissues and organs. This field can be broadly defined by three overlapping technology domains: cell therapy, gene therapy, and tissue engineering. In this course, we will explore these regenerative medicines from bench to bedside. We will discuss relevant biological, engineering, clinical, legal, regulatory, and ethical principles and perspectives to understand the emerging field of regenerative medicine. Specific topics will include induced pluripotent stem cells, bioartificial organs, cell-based immunotherapy, and gene editing techniques such as a CRISPR/Cas-9. In addition to gaining a scientific foundation, students will become familiar with the current state of the industry and the process of bringing these regenerative medicine products to market, including market trends and opportunities, process development and manufacturing, and commercialization challenges and successes. Readings will be drawn primarily from scientific journals. Prerequisite: 410.603 Advanced Cell Biology or equivalent.

This course covers basic ethical notions in the conduct of research into regenerative medicine. Specific case studies involving informed consent, gene editing, organ transplantation, animal research, sources of stem cell lines, the use of placebos, and eugenics will be covered. Students will examine navigating the institutional research boards of different universities, hospitals, and institutions. Authorship, peer review, conflict of interest, and copyright law will be discussed. Students will explore international differences and approaches to the ethics of regenerative medicine and how that affects practice and how patients are treated.

This course will involve discussion and debate on current topics concerning stem cell biology and the use of stem cells in biotechnology and therapeutics. Topics will include review and discussion of developmental and cell biology, stem cell characteristics, stem cell preparation and therapeutic uses, tissue engineering, global regulatory and ethical issues, and commercialization of stem cell therapy. The course will also detail state-of-the-art techniques for the experimental study of stem cells for biotechnology and biomedical applications. Current peer-reviewed literature and guest experts in the field will provide up-to-date information for discussion. Prerequisites: 410.603 Advanced Cell Biology or equivalent, 410.604 Cellular Signal Transduction or equivalent.

This course explores how engineered tissues and organotypic models are revolutionizing the drug development process. Students will learn about scaffold design for drug testing, 3D cultures, organoids, organ-on-chip technologies, and how these systems improve translational research outcomes. The course emphasizes applications in pharmacology, toxicology, and personalized medicine. Prerequisites: 410.603 Advanced Cell Biology or equivalent; 410.653 Regenerative Medicine: from Bench to Bedside.

This course examines manufacturing processes of current and emerging treatments that utilize therapies derived from biological sources as treatment for injury or disease, including cell and gene therapies. Students will become familiar with the state-of-the-art in biomanufacturing, stem cell differentiation, purification of biological materials, drug delivery, and explore challenges/gaps in current biological-based treatments. The course will explore processes at the development, pilot, and industrial scale. Prerequisites: 410.603 Advanced Cell Biology or equivalent; 410.653 Regenerative Medicine: from Bench to Bedside.

This laboratory course introduces students to the isolation, cultivation, and differentiation of stem cells. Students are introduced to reprogramming and differentiation protocols for various stem cell and cell progenitor types, as well as the basics of tissue engineering and scaling up cells into mini-bioreactors for large-scale use. The class will include industry-wide practices in cGMP. Please contact individual section instructors for hands-on laboratory exercises included in their section. Prerequisites: 410.604 Cellular Signal Transduction or equivalent, 410.652 Cell Culture Techniques or approval of academic advisor.

Students in Center for Biotechnology Education (CBE) MS programs have the opportunity to enroll in an independent research course. This elective course is an option after a student has completed at least eight graduate-level courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a research topic and a mentor who is familiar with their prospective inquiry and is willing to provide guidance and oversee the project. The research project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member teaching in the biotechnology program, a supervisor from the student’s place of work, or any expert with appropriate credentials. Students are required to submit a formal proposal for review and approval by the biotechnology program committee. The proposal must be received by the instructors ideally one month prior to, and no later than one week after, the beginning of the term in which the student wants to enroll in the course. Students must meet with a member of the program committee periodically for discussion of the project’s progress, and a written document, poster, and oral presentation must be completed and approved by the program committee and project mentor for the student to receive graduate credit. Additional guidelines can be obtained from the AAP administrative office. Prerequisites: Full-time students - six classes counting toward degree completion, Part-time students - eight classes counting toward degree completion

Students wishing to complete a thesis may do so by embarking on a two-semester thesis project, which includes the 410.800 Independent Research Project and 410.801 Biotechnology Thesis courses. This project must be a hypothesis-based, original research study. The student must complete 410.800 Independent Research Project and fulfill the requirements of that course, including submission of a project proposal, final paper, and poster presentation, before enrolling in the subsequent thesis course. For the thesis course, students are required to submit a revised proposal (an update of the 410.800 proposal) for review and approval by the faculty adviser and biotechnology program committee one month prior to the beginning of the term. Students must meet with the faculty adviser periodically for discussion of the project’s progress. Graduation with a thesis is subject to approval by the thesis committee and program committee and requires the student to present his/her project to a faculty committee both orally and in writing. Prerequisites: Successful completion of 410.800 Independent Research Project and a biostatistics class