State-of-the-Art Technology for Artificial Organ Implant

Tissue engineering, which is now being categorized as a form of regenerative medicine, can be defined as biomedical engineering to reconstruct, repair, and improve biological tissues. Research efforts in tissue engineering have been ongoing and it is emerging as one of the key areas of medical research. Furthermore, there are vast developments in tissue engineering, which involve leveraging of technologies from biomaterials, molecular medicine, biochemistry, nanotechnology, genetic and biomedical engineering for regeneration and cell expansion targets to restructure and/or repair human organs.

Research Scope

Tissue engineering is often referred to as regenerative medicine and reparative medicine. It is an interdisciplinary field requiring the combined efforts of cell biologists, engineers, material scientists, geneticists, clinicians, mathematicians etc., towards the development of biological substitutes that restore, maintain, or improve tissue function. Currently it has emerged as a rapidly diversifying field with the potential to address the worldwide organ shortage issue and comprises of tissue regeneration and organ replacement. Cells placed on or within the tissue constructs is the most common methodology in tissue engineering. Successful cell seeding as it is known depends on the fast attachment of engineered cell to scaffolds, high cell survival and uniform cell distribution over the scaffold. The cell seeding time is dependents strongly on the scaffold material and structure. Scaffolds act as an initial biochemical substrate for the new cells to proliferate, until the cells can produce their own extra-cellular matrix (ECM).

Tissue engineering has been a field of consistent research for just more than a decade. Still considered a nascent science, research in the field has offered and continues to offer an increasing number of substitutes for applications that would enable the human body to withstand pain and injuries inflicted upon it. While in the present time, it is a task to categorize tissue engineering into their respective categories, applications so far have been developed across three fronts namely materials, biomolecules, and cells. From the materials’ perspective, focus has largely been on the development of tissue scaffolds that serve as a base for the growth of the tissue. These biomaterials range from being fully bioresorbable to replaceable. At the next level lie biomolecules that are typically growth factors and proteins that tend to stimulate cell growth and division apart from the proteins that offer stability for the cellular layer over the scaffold as a result of the formation of the extracellular matrix. However, with developments in both these areas, key developments have been in cell sensitization and cellular reprogramming or dedifferentiation wherein committed cells that are destined to form a certain organ are returned to their native state. A vast degree of research has been carried out in the development of varied cell types out of which most of it has been done by means of autografts, allografts or xenografts. Yet there is a drive toward focusing on stem cell research owing to their totipotent and pluripotent abilities. As a result, most of the developments in tissue engineering have focused largely on the developments of stem cell-based developments that to a great extent have fuelled the innovations in organ regeneration.

In brief this study provides:
• A brief snapshot of the capabilities of existing technologies and standards in the tissue engineering and organ regeneration domain.
• An overview of the value chain networks existing in this domain and the assessment of the value chain networks.
• A sneak preview of the market impact of key innovations in this segment.
• A brief snapshot on the key business accelerators and challenges in the tissue engineering and organ regeneration domain.
• A brief snapshot on the demands from the end-user side.

Research Methodology

Primary Research
• Engineers
• CTOs/CEOs/CIOs
• Technical Architects
• Research Heads
• Strategic Decision Makers
• Technology Policy Heads

Secondary Research
• Technology Journals
• Periodicals
• Market Research services
• Technology Policy Information Sites
• Internal Databases
• Thought Leader Briefings

To provide a thorough analysis of each topic, Technical InsightsX analysts perform a review of patents to become familiar with the major developers and commercial participants and their processes. Building on the patent search, the analysts review abstracts to identify key scientific and technical papers that provide insights into key industry participants and the technical processes, on which they work.

The analysts then create a detailed questionnaire with content created to address the research objectives of the study, which functions as a guide during the interview process. While the analysts use structured questionnaires to guarantee coverage of all the desired issues, they also conduct interviews in a conversational style. This approach results in a more thorough exchange of views with the respondents and offers greater insight into the relevant issues than more structured interviews may provide.

The analysts conduct primary research with the key industry participants and technology developers to obtain the required content. Interviews are completed with sources located across the world, in universities, national laboratories, governmental and regulatory bodies, trade associations, and end-user companies, among other key organizations.

Our analysts contact the major commercial participants to find out about the advantages and disadvantages of processes and the drivers and challenges behind technologies and applications. Our analysts talk to the principal developers, researchers, engineers, business developers, analysts, strategic planners, and marketing experts, among other professionals.

The project management and research team reviews and analyzes the research data that are gathered and adds its recommendations to the draft of the final study. Having conducted both published studies and custom proprietary research covering many types of new and emerging technology activities as well as worldwide industry analysis, the management and research team adds its perspective and experience to provide an accurate and timely analysis.

The analysts then prepare a written final study for each project and sometimes present key findings in briefings to clients.

Key Findings

Tissue engineering is often seen as regenerative medicine and is considered an important solution to treat tissue and organ failure. It addresses the problem of organ transplant by implanting natural, synthetic, or semisynthetic tissues that are fully functional from the start, or those which differentiate into the required cells.
Technology advancement in the tissue engineering field and better understanding of market needs have been a major boost to growth of this market sector. Initial efforts have focused on skin equivalents for treating burns, but an increasing number of tissue types are now being engineered, as well as biomaterials and scaffolds used as delivery systems.
The tissue engineering market is marked by extensive R&D. Companies take several years to commercially launch products in this market. In the 1980s, R&D in tissue engineering and biomaterials took off. Companies expressed interest, and several biomedical engineering departments were established at major universities around the world.
For the biological component of tissue engineering, rapid advances are being made in identifying new cell types for use in tissue regeneration. An establishment of a consensus quality control program to ensure that tissue engineering products work and are safe to use is required.
The earlier focus of tissue engineering has been to utilize biomaterials to construct bioscaffolds and bioreactors; and tissue grafting to mimick the setting for the formation of desired tissue structures. Current research and development scenario tends to divert into cell-based technologies also based on a genetics approach.
Apart from the previous applications of common regeneration of bone, cartilage and skin, current targets have expanded to cardiovascular, kidney, pancreas, liver, spine, ligament, esophagus, cornea, thoracic, lung, nerve, lymphatic and blood vessels. Despite the huge potential of tissue engineering technologies and its remarkable impact in the healthcare sector, there are a number of challenges to be overcome for the recognition of tissue engineering as the main stream of medical technology applications.

Technology Snapshot

• Application of tissue engineering are for the reconstruction, remodeling, repair and regeneration of tissues damaged as a result of disease or injury.
• In the recent years, tissue engineering technology approach are mainly based on manipulation of stem cells, growth factors and biomaterials. The bioengineering strategy also involved integrative approach based on aforementioned technologies.

Area: Skin
Therapeutic applications:
Burns
Diabetic ulcers
Venous ulcers
Plastic surgery
Example of Tissue Engineering Modalities:
Autologous/allogeneic skin grafts
Epidermal/dermal substitutes

Area: Orthopedic
Therapeutic applications:
Non-union fractures
Cartilage damage
Ligament damage
Vertebral disc damage
Example of Tissue Engineering Modalities:
Demineralized bone matrix (DBM)
Hydroxyapatite and calcium carbonate bone graft substitutes biomimetic peptide systems
Nanocomposite bioscaffolds

Area: Heart
Therapeutic applications:
Myocardial infarction
Congestive heart failure
Dysfunctional heart valves
Peripheral vascular disorders
Abdominal aortic aneurysms
Example of Tissue Engineering Modalities:
Injection of biomaterials with myocardial cells or biomaterials only
Bioscaffolding to guide orientation of cardiomyocytes and yield anisotropic morphology similar to the native myocardium

Area: Ophthalmology
Therapeutic applications:
Retinal and macular degenerative diseases Bioadhesive for tissue regeneration
Cultivated oral mucosal epithelial transplantation (COMET)
Liver
Therapeutic applications:
Liver failure
Example of Tissue Engineering Modalities:
Extracorporeal artificial liver
Extracorporeal bioartificial liver (BAL)
Hepatocyte transplantation
Transplantable liver constructs

Area: Kidney
Therapeutic applications:
Urinary incontinence
Renal disease
Acute kidney injury
Example of Tissue Engineering Modalities:
Extracorporeal bioartificial kidney
Implantable bioartificial kidney (IBAK)

Technology Capability

Cell-Based Strategies
Direct in-vivo implantation of allogenic, isogenic, xenogenic and stem cells, and it is based on cells self-generating their own matrix. Tissues are typically built from several types of cells with tissue-specific composition and alignment in both two and three dimensions, and contain a similar tissue-specific extracellular matrix (ECM).

Application area: Cardiovascular diseases
Companies/Institutes:
Cardio3 BioSciences (Mont-Saint-Guibert, Belgium)
Product/ technology pipeline:
C-Cure (C3BS-CQR-1)
Harvesting patient's own cells from bone marrow followed by a process by incorporation of Cardiopoietic cocktail. The patient will received the cell therapy via injection into the heart. stem cells to achieve repair mechanism which induced by the transformation of the bone marrow stem cells into cardiac tissue progenitor cells.

Application area: Liver Cirrhosis / Ischemic Heart Failure
Companies/Institutes:
Kanazawa University (Kanazawa, Japan)
Product/ technology pipeline:
Liver regeneration with mesenchymal stem cells from adipose tissue obtained from stromal cells via intrahepatic arterial catheterization.
Currently under clinical trial at Kanazawa University Hospital.
Heart regeneration therapy of autologous adipose tissue-derived stromal cells through cardiac catheterization.

Application area: Site specific injuries wound healing and Scar repair
Companies/Institutes:
Avita Medical
Product/ technology pipeline:
ReCell Spray-On Skin facilitate a skin regeneration during by utilization of patient's own skin cells by pray on the affected site. The cell suspension, via spraying contains the optimized mixture of healthy cells of different types to promote healing (keratinocytes and skin stem cells, or progenitor cells), skin structure (fibroblasts) and cells that reintroduce normal color (melanocytes) in areas where the pigmentation has become too dark or white as a result of injury, scars or disease.

Growth-Factor-Based Strategies
Using growth factors and controlled-released systems as the signaling molecules to regulate the cascading of cellular functions such as proliferation, differentiation, migration, adhesion, gene expression, and eventually the formation of desired cell types and tissues.

Application area: Wound healing
Companies/Institutes:
Plastic and Reconstructive Surgery Service, Centre Hospitalier Universitaire Vaudois (Lausanne, Switzerland)
Product/ technology pipeline:
Keratinocyte suspension combined with an autologous platelet concentrate to the donor site

Application area: Soft tissue healing
Companies/Institutes:
MiMedx Group, Inc. (Marietta, US)
Product/ technology pipeline:
AmnioFix is the allograft amniotic membrane produced from the company’s proprietary PURION Process which enables protection of the delicate scaffold during processing therefore ensure collagen matrix structure stay intact. AmnioFix is designed for application in regeneration of damaged or diseased tissues by delivering human extracellular matrix components, essential growth factors, and specialized mediating cytokines. AmnioFix can be stored at room temperature for five years without requirement of refrigeration. Therefore the product can readily applied without thawing process.

Application area: Orthopedic diseases and injuries
Companies/Institutes:
TissueGene, Inc. (Rockville, US)
Product/ technology pipeline:
The technology involves transducing cells with a retroviral vector constructed to express a therapeutic protein at a target therapeutic level and duration of time. These modified cells were mixed with unmodified cells to create the various therapeutic products. The product candidates is available in the form of injection and the engineered cells produce therapeutic growth factors to induce repair and regeneration of tissue.

Table Of Contents

Table of Contents

Executive Summary 3
• Research Scope
• Research Methodology
• Key Findings
Technology Snapshot and Trends 8
• Technology Capability
• Technology Value Chain
Impact Assessment and Analysis 15
• Market Impact of Proprietary Technologies
• Business Drivers
• Business Challenges
Diffusion of Innovations and Needs Assessment 24
• Technology Adoption Cycle
• Demand Side Analysis
Opportunity Evaluation and Roadmapping 27
• Scenario Modeling
• Technology Roadmap
• Technology Management Strategies
Key Contacts and Patents 31
Decision Support Database 36
The Frost and Sullivan Story 43

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