Course

Unit 1

Unit 1:

Introduction to Stem Cells and Their Therapeutic Potential, Definition and types of stem cells: embryonic, adult, and induced pluripotent stem cells (iPSCs), Properties of stem cells: self-renewal and differentiation, Historical development of stem cell research, Overview of stem cells in regenerative medicine

Unit 2

Unit 2:

Stem Cell Sources and Characterization, Sources of stem cells: bone marrow, adipose tissue, umbilical cord blood, and reprogrammed somatic cells, Techniques for isolation, culture, and expansion, In vitro and in vivo characterization methods, Stem cell markers, potency testing, and quality control

Unit 3

Unit 3:

Clinical Applications in Regenerative Medicine, Stem cell therapy in hematological, neurological, cardiovascular, musculoskeletal, and ocular disorders, Case studies highlighting clinical outcomes, Overview of clinical trial phases and results, Current therapeutic products and treatment protocols

Unit 4

Unit 4:

Translational Research and Preclinical Studies, Preclinical models for evaluating stem cell therapies, Safety, efficacy, and dosage considerations, Delivery systems and administration routes, From lab research to Investigational New Drug (IND) applications

Unit 5

Unit 5:

Challenges in Stem Cell Therapies, Ethical, legal, and social implications, Tumorigenicity and immune rejection risks, Issues in scalability and reproducibility, Manufacturing and standardization challenges

Unit 6

Unit 6:

Regulatory Landscape and Emerging Trends, Regulatory frameworks: FDA, EMA, and other global agencies, Guidelines for clinical trials and product approval, Post-market surveillance and safety monitoring, Innovations: gene-edited stem cells, organoids, personalized medicine, and biomaterial integration

(45 classes)

Preamble

Stem Cell Therapies is a course designed to explore the therapeutic applications of stem cells in treating various diseases and disorders. The course will cover current clinical strategies, challenges, and advancements in stem cell-based interventions. Through lectures and case studies, students will learn about the potential of stem cells in regenerative medicine and the translational steps from bench to bedside.

Course Outcome:

CO1: Explain the fundamental properties of different stem cell types and their roles in regenerative medicine.

CO2: Describe the sources, isolation techniques, and characterization methods used in stem cell research and therapy.

CO3: Evaluate the clinical applications of stem cell therapies across various disease conditions using case studies and trial data.

CO4: Interpret the translational steps from preclinical studies to clinical implementation, including safety and delivery considerations.

CO5: Analyze the ethical, legal, and technical challenges associated with the development and application of stem cell-based therapies.

CO6: Discuss the regulatory frameworks and recent innovations shaping the future of stem cell therapies.

Program outcome

PO1: Bioscience Knowledge

PO2: Problem Analysis

PO3: Design/Development of Solutions

PO4: Conduct Investigations of complex problems

PO5: Modern tools usage

PO6: Bioscientist and Society

PO7: Environment and Sustainability

PO8: Ethics

PO9: Individual & Team work

PO10: Communication

PO11: Project management & Finance

PO12: Lifelong learning

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

Program-specific outcome

PSO 1 – Emerging technologies in cell therapy

PSO 2 – Biomolecules in Medicine

PSO 3 – Molecular dysregulation in diseases

PSO 4 – Molecular technology in diagnosis and therapy

PSO 5 – Applying lab discoveries to clinical practice

PSO 6 – Advanced techniques in cell culture, gene editing, and bioprocessing

PSO 7 – Statistical methods to interpret and validate diagnostic results

PSO 8 – Integrate cell therapy into personalized medicine

PSO 9 – GMP and regulatory practices in cell therapy production

PSO 10 – Bioinformatics and biological data use

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

Textbook

Lanza, R., Gearhart, J., Hogan, B., Melton, D., Pedersen, R., Thomson, J., & Wilmut, I. (Eds.). (2006). Essentials of stem cell biology (2nd ed.). Academic Press.

Reference book

Quesenberry, P. J., Stein, G. S., Forget, B. G., & Weissman, S. M. (Eds.). (2001). Stem cell biology and gene therapy. John Wiley & Sons.