skilldevelopment.cpe@lpu.co.in

What you'll learn

Course Description The Foundation Course in Stem Cell Research and Clinical Translation (30 hours) provides an in-depth orientation to the 2025 International Society for Stem Cell Research (ISSCR) guidelines. Designed for students, early-career researchers, and healthcare professionals, this course introduces the fundamental ethical principles governing stem cell science and explores laboratory-based human embryonic stem cell research, embryo research, and associated review processes. Special emphasis is placed on procurement, informed consent, and banking of human stem cell lines, alongside mechanisms for oversight and enforcement. Participants will examine the pathway of clinical translation—from preclinical studies, manufacturing standards, and clinical trials to regulatory approval, economics, and global access. Critical discussions on unproven stem cell interventions, genome editing, and in utero applications highlight the evolving landscape of responsible innovation. The course also underscores best practices in communication, transparency, and adherence to international standards, ensuring that learners are equipped to critically evaluate and contribute to ethically sound and scientifically rigorous stem cell research. Learning Outcomes By the end of this course, learners will be able to: Explain the ethical and regulatory frameworks guiding stem cell research. Differentiate ISSCR review categories and their applications. Apply principles of informed consent, procurement, and cell banking. Critically assess preclinical and clinical translation pathways. Evaluate challenges in unproven interventions and medical innovation. Demonstrate understanding of communication standards and global best practices.

  • Introduction to ISSCR guidelines
  • Research and Health care communication
  • National and International Regulatory framework
  • 2.1 Review Processes 2.2 Research Review Categories 2.2.1 Category 1 2.2.2 Category 2 2.2.3 Category 3 2.3 Procurement and Informed Consent of Human Biological Materials 2.3.1 Review Process for the Procurement of Human Cells and Tissues 2.3.2 Informed Consent for the Donation of Human Cells and Tissues 2.3.3 Payments to Individuals Donating Cells and Tissue for Research 2.4 Derivation, Banking and Distribution of Human Stem Cell Lines 2.5 Mechanisms for Enforcement
  • 3.1 Classifying Stem Cell-, Cell-, and Tissue-based Interventions 3.2 Cell Processing and Manufacture 3.2.1 Sourcing Material 3.2.2 Manufacture 3.3 Preclinical Studies 3.3.1 General Considerations 3.3.2 Safety Studies 3.3.3 Efficacy Studies 3.3.4 Transparency and Publication
  • 3.4 Clinical Research 3.4.1 Oversight 3.4.2 Standards for Clinical Research Conduct 3.4.3 Transparency and Reporting of Research Results 3.4.4 Issues Particular to Early Phase Trials 3.4.5 Issues Particular to Late Phase Trials 3.4.6 Research Subject Follow-up and Trial Monitoring 3.4.7 Issues Particular to Genome Editing of Somatic Stem Cells 3.4.8 Clinical Research that Involves Heritable Changes to the Human Genome 3.4.9 Clinical Research that Involves in utero Stem Cell and Genome Editing Interventions 3.5 Unproven Stem Cell-based Interventions and Medical Innovation 3.6 Clinical Application 3.6.1 Regulatory Approval 3.6.2 Access and Economics

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Dr. Kanav Khera
Professor

Working as Professor, Dept of Pharmacy Practice with more than 17 years of experience in clinical research/biomedical ethics/evidence-based medicine, antibiotic stewardship programs, pharmacovigilance, drug safety, clinical trials, and outcome research. Dr Kanav Khera is also an associate member secretory of the Institutional Ethics Committee at School of Pharmaceutical Sciences, LPU. Dr Kanav Khera had vast experience in providing pharmaceutical care services in Tertiary care hospitals and handling medication errors and related problems. Had published more than 40 research papers in national and international journals and was invited as a guest speaker at various events. Dr Kanav Khera has been honoured with Best teacher and excellence in teaching awards and and also worked as Scientist 1 in a clinical research organization conducting clinical trials