Advanced Tissue Engineering and Regenerative Medicine Training

Advanced Tissue Engineering and Regenerative Medicine Training

Introduction

The Frontier of Medicine The field of Regenerative Medicine (RM) and Advanced Tissue Engineering (ATE) represents a groundbreaking paradigm shift in healthcare, moving beyond disease management to focus on true functional Regeneration and repair. Advanced Tissue Engineering and Regenerative Medicine Training delves into the intricate synergy of Cell Biology, advanced Biomaterials, and sophisticated Biofabrication techniques. Professionals will gain mastery over the core principles required to develop and translate innovative Cell-Based Therapies from designing complex Bioreactors for ex vivo tissue maturation to utilizing cutting-edge 3D Bioprinting for creating personalized Organoids and functional tissue constructs. The training is essential for navigating the evolving Regulatory Landscape and pushing the boundaries of what is possible in treating chronic diseases and traumatic injuries.

Participants will explore the latest advancements in Stem Cell Technology, delve into the mechanics of Extracellular Matrix (ECM) Mimicry, and understand the critical role of Signaling Pathways and Growth Factors in directing cellular fate. Key to the curriculum is the emphasis on Precision Medicine, using AI-Driven Analytics to personalize therapeutic strategies. Upon completion, learners will be equipped with the expertise to design, optimize, and critically evaluate next-generation regenerative products, preparing them to lead Pre-clinical and Clinical Trial efforts in this high-growth Biotechnology sector, ensuring robust and scalable solutions for Patient-Specific Implants and functional tissue replacement.

Course Duration

10 days

Course Objectives

1. Master the principles of Tissue Engineering Triad.
2. Evaluate current and next-generation Biomaterials for tissue-specific applications.
3. Analyze advanced Stem Cell Technologies for therapeutic potential and ethical considerations.
4. Develop robust protocols for 3D Bioprinting and Biofabrication of complex, vascularized tissue constructs.
5. Design and operate sophisticated Bioreactor Systems for ex vivo tissue maturation and industrial scale-up.
6. Apply principles of Mechanobiology and Extracellular Matrix (ECM) Mimicry to engineer functional tissues.
7. Interpret the role of Gene Therapy and CRISPR applications within the regenerative medicine context.
8. Formulate Controlled Drug Delivery Systems (DDS) integrated into scaffold architectures.
9. Assess the efficacy of Personalized Medicine and Patient-Specific Implants using advanced analytics.
10. Critique the current Regulatory Landscape (FDA/EMA) for Advanced Therapy Medicinal Products
11. Lead Translational Research efforts from benchtop concept to First-in-Human clinical trials.
12. Explore the development and application of functional Organoids and Organs-on-a-Chip for disease modeling.
13. Integrate Artificial Intelligence (AI) and Machine Learning for predictive modeling in cellular differentiation and therapy optimization.

Target Audience

1. Biomedical Engineers and Materials Scientists specializing in scaffold design.
2. Cell and Molecular Biologists and Biotechnologists.
3. R&D Scientists in pharmaceutical and medical device companies.
4. Clinical Researchers and Physicians seeking to integrate cell-based therapies.
5. Regulatory Affairs Professionals in the ATMP sector.
6. Post-doctoral Researchers and PhD Students in related fields.
7. Process Engineers involved in GMP manufacturing scale-up.
8. Venture Capital Analysts and Business Development Professionals

Course Modules

Module 1: Foundations of Regenerative Medicine (RM)

• The Tissue Engineering Triad.
• Distinction between Tissue Repair, Replacement, and True Regeneration.
• Historical perspectives and landmark achievements in RM.
• Introduction to key therapeutic targets.
• Ethical and societal challenges in commercializing Cell-Based Therapies.
• Case Study: The clinical translation of Apligraf and Dermagraft for skin regeneration

Module 2: Advanced Stem Cell Technology

• Isolation, characterization, and banking of Mesenchymal Stem Cells
• Induced Pluripotent Stem Cells.
• Hematopoietic Stem Cell (HSC) transplantation principles and clinical success.
• Strategies for targeted differentiation and lineage specification.
• Quality control and release criteria for clinical-grade cell products.
• Case Study: Use of iPSC-derived Cardiomyocytes for drug screening and the potential for cardiac patch engineering.

Module 3: Biomaterials and Scaffold Design

• Classification of biomaterials.
• Designing scaffolds with bioactive and mechanical cues.
• Electrospinning, freeze-drying, and particulate leaching.
• Smart Hydrogels, injectable systems, and self-assembling peptides.
• Biocompatibility, biodegradation kinetics, and non-toxic degradation products.
• Case Study: Development of novel, porous Calcium Phosphate scaffolds for large-segment bone defect repair.

Module 4: 3D Bioprinting and Biofabrication

• Principles of bioprinting technologies.
• Development and optimization of Bio-inks
• Printing complex geometries.
• 4D and 5D bioprinting concepts.
• Software and CAD/CAM for designing Patient-Specific Implants.
• Case Study: Bioprinting of a multi-cellular Tracheal Replacement using native ECM bio-ink for pre-clinical implantation.

Module 5: Bioreactors and Ex Vivo Maturation

• Types of bioreactors.
• Engineering a controlled Microenvironment.
• Optimizing mechanical and biochemical stimulation for tissue development.
• Scale-up and process validation for Good Manufacturing Practice
• Sensors and real-time monitoring of construct quality and maturation.
• Case Study: Utilizing a Cardiac Bioreactor to apply cyclic strain to a developing heart patch to enhance functional contractility.

Module 6: Cardiovascular Tissue Engineering

• Scaffolding and cell sources for cardiac muscle and vascular grafts.
• Challenges of creating thick, functional, and Vascularized Myocardium.
• Engineering small-diameter vascular grafts with long-term patency.
• Heart valve tissue engineering.
• In situ regeneration strategies for chronic heart failure.
• Case Study: Clinical trials of Engineered Vascular Grafts using autologous cells in patients with peripheral artery disease.

Module 7: Orthopedic and Musculoskeletal Regeneration

• Bone tissue engineering.
• Cartilage repair strategies.
• Tendon and ligament regeneration.
• Delivery of Growth Factors and their controlled release.
• Addressing joint and spinal disc degeneration with cell therapies.
• Case Study: Second-generation ACI techniques and the bioengineering of an injectable, load-bearing Cartilage Hydrogel.

Module 8: Neural Tissue Engineering

• Challenges of regenerating the Central and Peripheral Nervous Systems.
• Designing Nerve Conduits to guide axonal outgrowth and bridge gaps.
• Cell sources for spinal cord injury.
• Biomaterials with conductive and neurotrophic properties.
• Retinal and ocular tissue regeneration using layered cell sheets.
• Case Study: Development and human trials of an engineered Nerve Guidance Conduit for peripheral nerve repair.

Module 9: Skin and Soft Tissue Engineering

• The biology of wound healing and the need for a functional dermal component.
• Bioengineered skin substitutes.
• Treating severe burns and chronic wounds
• Fat and soft tissue reconstruction using adipose-derived stem cells
• Minimizing scarring and enhancing aesthetic outcomes.
• Case Study: The use of Integra Dermal Regeneration Template a pioneering bovine collagen/silicone construct.

Module 10: Immunomodulation and Acellular Scaffolds

• Understanding the host immune response to implanted biomaterials and cells.
• Strategies for immune evasion and tissue integration.
• Techniques for Decellularization of native organs to create natural ECM scaffolds.
• Recellularization of acellular scaffolds with patient-specific cells.
• Xenotransplantation and the challenge of immune rejection.
• Case Study: Development and initial transplantation of a Decellularized Whole-Organ Trachea reseeded with autologous cells.

Module 11: Drug Delivery and Therapeutics Integration

• Incorporating therapeutic agents into scaffolds.
• Sustained and controlled release kinetics for long-term bioactivity.
• Gene delivery systems.
• Targeted delivery to the regenerative site for enhanced efficacy.
• Hybrid systems combining cells, materials, and active pharmaceutical ingredients
• Case Study: Engineering a Biodegradable Scaffold that sequentially releases an anti-inflammatory drug followed by a pro-regenerative Growth Factor.

Module 12: Organoids and Disease Modeling

• Principles of Organ-on-a-Chip and Microphysiological Systems.
• Culturing and characterizing functional 3D organoids
• Using organoids for personalized drug toxicity screening and efficacy testing.
• The potential of Body-on-a-Chip models for multi-organ interactions.
• Advanced imaging and analytical tools for MPS analysis.
• Case Study: Utilizing Human Liver Organoids derived from iPSCs to predict drug-induced liver injury

Module 13: Clinical Translation and Regulatory Affairs

• The journey from bench to bedside.
• GMP/GLP requirements for manufacturing ATMPs.
• Navigating global regulatory pathways.
• Clinical trial design specific to regenerative products.
• Risk assessment, ethical oversight, and patient consent for novel therapies.
• Case Study: Analysis of the Kymriah approval pathway as an example of a successful ATMP translation.

Module 14: Quantitative Analysis and Quality Control

• Biochemical assays for cell differentiation and matrix production.
• Mechanical testing methods for engineered tissue constructs
• Confocal microscopy, MRI, and PET for in vivo tracking.
• Statistical analysis and data integrity in Translational Research.
• Developing standardized protocols for product release and lot consistency.
• Case Study: Standardization of quality metrics for Engineered Cartilage constructs before implantation.

Module 15: Future Directions and Commercialization

• In Vivo Reprogramming and gene editing
• Integration of Artificial Intelligence for predictive tissue design and process optimization.
• Global market trends, investment, and intellectual property protection.
• Strategies for scalable, cost-effective manufacturing and market access.
• Addressing long-term safety, durability, and commercial viability.
• Case Study: The commercial trajectory and IP strategy of Osiris Therapeutics and the market for Mesenchymal Stem Cell products.

Training Methodology

The course will employ a Blended Learning Approach focusing on Active and Collaborative Learning:

1. Expert-Led Lectures.
2. Interactive Workshops.
3. Case Study Analysis.
4. Grant/Protocol Development.
5. Virtual Lab Simulations.
6. Guest Speaker Series.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.