tissue engineering · 2018-08-09 · tissue engineering: innovations in kin tissue engineering a...

Tissue Engineering: Innovations in Skin Tissue Engineering

A Frost & Sullivan Whitepaper

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Tissue Engineering:Innovations in Skin Tissue Engineering

A Frost & Sullivan White Paper



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Table of Contents

OVERVIEW

INTRODUCTION

WHY TISSUE ENGINEERING IS IMPORTANT

TISSUE ENGINEERING: MARKET APPLICATION

TISSUE ENGINEERING: MARKET DRIVERS AND CHALLENGES

TISSUE ENGINEERING: MARKET OPPORTUNITIES

CELL TISSUE TECHNOLOGY - MALAYSIA’S REVOLUTIONARY PIONEER

IN TISSUE ENGINEERING

REFERENCES

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Overview

Technology advancements in medical and bioengineering are transforming the future of healthcare, par ticularly with the emergence of Tissue Engineering. Tissue Engineering has been evolving in the past 30 years from bench to bedside, with laboratory experiments turning into prototypes and now maturing into clinical trials. To date, the development of skin, bones, car tilages, nerves, and cornea has been successful, and there is potential to develop various other ar tificial organs.

Tissue Engineering, which can be placed under the umbrella of regenerative medicine, is an interdisciplinary field of medicine and bioengineering using a person’s cells to develop new tissue and organ substitutes that can replace, restore or repair a damaged or diseased tissue or organ in the person’s body.

Benefits of Tissue Engineering include significant advantages over organ transplantation, such as shorter waiting time, reduced risk of transplanted organ or tissue rejection, as well as addressing donor organ or tissue unavailability. Continual research in this thriving field also allows for the invention of new and innovative techniques that may change medical treatment strategies and ultimately reduce healthcare costs.

However, the field faces a multitude of challenges including complex regulatory processes, funding issues and slow commercialisation and clinical translation of tissue engineering technologies that has hampered the growth of the market.

Tissue Engineering technologies have vast applications across all modalities of the human body. Skin regeneration was one of the first organ regeneration researches to have been performed

and subsequently technology advancements have been made to develop more complex tissue regenerations such as hear t, lung, and kidney tissues. Although much of the research is still a long way from patient-readiness, various new approaches and medical technologies such as 3D bio printing may infuse renewed confidence in developing more personalised treatments and medicines for patients.

The rising need for more advanced and personalised treatments is driving the Tissue Engineering market. The growing ageing population and increase in chronic diseases and lifestyle options are encouraging demand for replacement materials to repair damaged tissues or diseased organs. New technologies and collaborations among various stakeholders in the Tissue Engineering field are set to boost the market. The future of Tissue Engineering looks very promising as every day researches unlock new techniques that can change the future of healthcare.

What is Tissue Engineering?Tissue Engineering combines medical advancements and bioengineering processes to develop new tissues/organs from a donor body and engineer them into tissues or organs that will be re-implanted into the host

Why is Tissue Engineering important? Tissue Engineering aims to regain normal functionality for patients by replacing, restoring or repairing diseased or damaged tissues or organs, giving new hope for medical conditions for which few or no treatment exist


Tissue Engineering: Innovations in Skin Tissue Engineering4

Introduction

Tissue Engineering is an important solution for treating organ and tissue damage or failure. It emerged from the need to address various challenges around tissue and organ transplantation procedures such as organ and tissue shortages, inaccessibility to donated tissues and organs and long waiting times for them, and the incompatibility of a donor tissue or organ. The loss or damage of an organ or tissue can have a devastating physical, emotional, and social impact on a person, and can even be life-threatening. Every year, thousands of people wait for a life-saving organ or tissue transplant; tragically, many die before their turn for the procedure arrives. In fact, according to an ar ticle in the New Straits Times, the Health Ministry of Malaysia reported that in 2017; the country had around 21,000 patients on a waiting list for organ transplants including those suffering from kidney, liver, hear t, and lung failures.

Technology advancements in Tissue Engineering are rapidly transforming this promising field which has proven to be a potential alternative to tissue or organ transplantation procedures.

Exhibit 1 shows the basic components of Tissue Engineering. The process star ts with harvesting a tissue sample from the body. The living cells, extracted from these solid or fluid tissue samples such as bone, muscle, blood, skin, and mucosa, are used as the building blocks of the tissue engineering process. These cells are then isolated, expanded and seeded onto a 3D biodegradable scaffold that provides an optimum environment for the growth and differentiation of the cells for tissue formation. Successful cell seeding depends on the fast attachment of engineered cells to scaffolds, high cell survival rates, and uniform cell distribution over the scaffold. The cell seeding time is highly dependent on the scaffold material and structure. The newly formed tissues are then implanted back into the host, where these tissues mimic or grow into the required functionality.

Exhibit 1: Basic Components of Tissue Engineering

Cells froma biopsy

BiomaterialScaffold

GrowthFactors

Tissue Engineered Structure/Product

Source: Frost & Sullivan



Potential Benefits of Tissue Engineering

Exhibit 2 below summarises the potential benefits of tissue engineering.

Exhibit 2: Potential Benefits of Tissue Engineering

Improves quality of lives and saves lives

Reduces waiting time

for organ/tissue transplantation

Reduces healthcare

expenditure

Potential to change or create

new methods to cure cer tain

disease

Offers an alternative to

current therapies, which are not

always successful

Overcomes problem of limited

organ/tissue donations

Eliminates or reduces risk

of rejection of transplanted organ/tissue

Why Tissue Engineering

Matters



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“For every 7 people in Malaysia, 1 person needs an organ/tissue transplant. The demand for organ donation is not sustainable and

tissue engineering is the way forward.”

Dr. Khairul Idzwan Baharin, CEO and Managing Director of Cell Tissue Technology Sdn Bhd

Tissue Engineering research continues to benefit the medical community and patients. Limited organ donations cannot fulfil the demand; hence the ability to engineer tissues and organs to replace those damaged beyond regeneration is seen as an alternative that can save a lot of lives. Tissue Engineering improves and prolongs the quality of life as the cells coming from the same patient needing the transplant significantly reduces or eliminates the risk of rejection or cross-infection, decreasing the need for immunosuppressant or antibiotic treatment and ultimately lowering healthcare costs.

Tissue Engineering is also considered an alternative to current treatments for organ/tissue failure/injury such as transplantation surgery, medical devices, synthetic prostheses or even drug therapies, which are not always successful. Fur thermore, Tissue Engineering offers an immense scope in changing the medical approach to cure cer tain diseases that are untreatable with current therapies. For example, developing human tissues in the laboratory to test new cancer drugs shortens the drug development time and may even lead to personalised medicines that treat the patients’ specific diseases.



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Tissue Engineering:Market Applications

Tissue Engineering has vast applications, having evolved from lab-based research into potential applicable treatments for patients. While common applications include regeneration of skin, bone, car tilage, cornea, and nerve, technology advancements have expanded tissue regeneration to more complex organ tissues like the hear t, kidney, pancreas, lung, liver, spine, ligament, oesophagus, and trachea. Although complex organ tissues have been successfully developed in the lab such as hear t and lung tissues and trials have been performed to implant patients with ar tificial organs such as a supplemental bladder and an ar tificial trachea, these procedures are still experimental and not very feasible.

As technology improves, more innovations are expected. For example, 3D bio printing is the latest application in Tissue Engineering set to revolutionise the medical industry, as it enables cells, tissues, and organs to be printed on demand. Imagine a future where a patient requiring a hear t bypass surgery would only need a stem cell injection to grow a new blood vessel bypassing the blocked vessel. Exhibit 3 highlights some potential indications for Tissue Engineering applications.

APPLICATION

Skin

Eyes

Bone and Cartilage

Burns, diabetic ulcers, wound management venous ulcers, skin-related plastic surgery, aesthetics and cosmetics

Retinal and macular degenerative diseases

Osteoar thritis, fractures

• Autologous/allogeneic skin grafts• Epidermal/dermal substitutes

• Bioadhesives for tissue regeneration• Cultivated oral mucosal epithelial transplantation (COMET)

• Demineralised bone matrix (DBM)• Hydroxyapatite and calcium carbonate bone graft substitutes• Biomimetic peptide systems• Nanocomposite bioscaffolds

INDICATION EXAMPLE OF TISSUE ENGINEERING MODALITIES

Exhibit 3: Some Potential Indications for Tissue Engineering Application

Source: Frost & Sullivan, “Advances in Tissue Engineering and Organ Regeneration: Technology Market Penetration and Roadmapping; State-of-the-Art Technology for Artificial Organ Implant”, 2013.



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Tissue Engineering:Market Drivers And Challenges

Based on the multitude of areas and applications, the market potential for Tissue Engineering is enormous. The evolving market needs resulting in increasing demand for more advanced treatments,

technological advancements as well as increased collaborations and synergies among the market par ticipants are expected to drive the Tissue Engineering market as shown in Exhibit 4.

Exhibit 4: Tissue Engineering Market Drivers

Rising demand for advanced treatments to heal and regenerate biological structures

• A burgeoning ageing population, along with longer life expectancy, rising chronic diseases and active lifestyles of the young leading to higher risks of physical injuries, are driving demand for replacement material to repair damaged tissues or diseased organs. Existing surgical and implant treatments are not always successful, and may face non-biocompatibility and limited donor availability. All these factors call for better and alternative treatments, and Tissue Engineering is seen to fill the gap. For instance, the increasing incidence of car tilage destruction due to osteoar thritis and rheumatoid ar thritis has resulted in the massive demand for car tilage repair or substitute



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Technology advancements driving adoption and revenues in the market

Opportunities of strategic partnerships via mergers and acquisitions

• Tissue Engineering research and development (R&D) involves biomedical engineering, material science, molecular biology, and nanotechnology. The integration of multidisciplinary technologies in Tissue Engineering has enhanced the technological capability in tissue engineered products

• Diagnostic and testing devices for validating the safety and efficacy of tissue-engineered products before clinical trials, and specific imaging systems and micro-dissecting technologies are expected to facilitate Tissue Engineering R&D and provide emerging opportunities for its application in healthcare

• Innovations in Tissue Engineering technologies, coupled with rising applications in the medical field, are creating rich opportunities for mergers and acquisitions in the global market. Par tnerships via co-development, joint research or licensing could enable a mutually beneficial situation among companies, as well as between industry and academia

• Large pharmaceutical or biotechnology companies could acquire companies owning the potential Tissue Engineering technology platform, providing financial support to fur ther validate and enhance their existing technologies

• Tissue Engineering companies may collaborate with other R&D companies to integrate and tailor the technology into a game-changing solution for specific industries

Source: Frost & Sullivan, Advances in Tissue Engineering and Organ Regeneration: Technology Market Penetration and Roadmapping, 2013. Frost & Sullivan, U.S. Tissue Engineering Markets, 2012

Despite the huge potential of Tissue Engineering technologies and its remarkable impact on the healthcare sector, Tissue Engineering has to overcome several challenges to becoming a mainstream treatment option.

The pace of development has been hindered by complex regulatory processes, challenging clinical translation of regenerated tissue for patient use, funding issues and slow commercialisation of tissue engineering technologies. Exhibit 5 sums up these challenges.



Exhibit 5: Tissue Engineering Market Challenges

Complex and uncertain regulations and protocols hindering growth

Complex clinical translation of tissue regeneration mechanisms slows down scalability of product development

High cost of research and funding required impeding growth in the market

Lack of a clear reimbursement or insurance coverage system hampering the commercialisation and growth of market applications

• Current regulations for cer tain tissue regeneration technologies and products lack substantial clinical data and safety assessment, thereby delaying their approvals and affecting the commercialisation process of marketing the products

• Tissue Engineering technologies and procedures involve living cells, biomaterials, and precise consistency in positioning the bio scaffolding in the patient’s organ or system. The process design and complexity are increasing as scientists and researchers consider various functional applications in the body. These include fine tuning the variability of cells (getting enough cells and cell types to engineer a tissue or organ) and optimising the vascularity of blood vessels in the organ (engineering the blood vessels to supply nutrients, oxygen, and signals to bioengineered tissues and organs for their sustenance)

• R&D in the Tissue Engineering market requires a lot of funds and time from conception to launch

• Companies and academic institutions spend large sums of money to conceptualise products and market them. Providing adequate data to prove the products’ cost efficiency becomes a challenge

• The high cost of R&D in the Tissue Engineering market are forcing companies to charge a premium for the products, thus increasing their prices. The high price of tissue-engineered products is a challenge to their market adoption rate

• Reimbursement approval is critical in promoting the application of technologies. However, uncer tainties in regulations and ambiguous product categorisation of some cell-based therapies and bio scaffolds may challenge reimbursement models at the initial stage, specifically in justifying the reimbursement coverage for different diseases and Tissue Engineering technologies

Source: Frost & Sullivan, Advances in Tissue Engineering and Organ Regeneration: Technology Market Penetration and Roadmapping, 2013. Frost & Sullivan, U.S. Tissue Engineering Markets, 2012



Tissue Engineering:Market Opportunities

Still in the growth stage, the Tissue Engineering field offers tremendous untapped opportunities for all stakeholders across its technology value chain, shown in Exhibit 6.

Its typical R&D flow involves conceptualisation, product design/development (encompassing organ-forming cells, tissue scaffolds, and growth factors), process validation, commercialisation, and post-market surveillance.

Exhibit 6: Tissue Engineering Technology Value Chain

Source: Frost & Sullivan

Research & Development• Universities• Research institutions• Biomaterials/Biotechnology

companies

Clinical Trials• Hospitals/Clinics• Contract research

organisations

Commercialisation• Hospitals/Clinics• Medical device companies• Biotechnology companies

Regulatory Bodies• Food and Drug Administration (FDA, US)• European Medicines Agency (EMA, EU)• Current Good Manufacturing Practices (cGMP)• National Pharmaceutical Control Bureau

(NPCB, Malaysia)



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The entire value chain offers vast potential scale-up opportunities for the different stakeholders operating in this space, be they research institutions or universities developing new techniques and forming star t-ups, companies or hospitals conducting clinical trials, regulatory bodies conducting safety and efficacy oversight or any entity collaborating with large corporations. While many Tissue Engineering companies are considering various technologies for different types of diseases or formulating solutions to healthcare problems, most are still far from commercialisation and patient-readiness.

Of the few companies that have developed propriety technologies especially in the skin and bone areas, one that stands out is Cell Tissue Technology Sdn Bhd (CTT). CTT has developed a patented technology to cultivate autologous tissue engineered skin that mimics the natural human skin and is recognised as a pioneer in Tissue Engineering that has gone through the entire technology value chain and even established its own manufacturing laboratory for its products.

Cell Tissue Technology – Malaysia’s Revolutionary Pioneer in Tissue Engineering

Cell Tissue Technology Sdn Bhd (CTT) is a Malaysian advanced medical technology-based company incorporated in 2010 as a spin-off from Universiti Kebangsaan Malaysia (UKM), one of the leading research universities in Malaysia. CTT is recognised as Malaysia’s first Tissue Engineering company, pioneering in the field of Tissue Engineering, Regenerative Medicine, and Cellular Therapy. CTT focuses on delivering innovative solutions to improve and enhance the health and quality of people’s lives worldwide through its world-class products aimed at saving lives to rejuvenating, categorised under the three pillars of manufacturing purposes:

1. Clinical Use – Tissue Engineered Medical Products (TEMPs) for medical treatment

2. Cosmetic Use – Advanced cellular-based products for totally personalised aesthetics solutions

3. Research/Industrial Use – Tissue engineered and cell-based products for industrial or research use

In line with its commitment to enhance its technological capabilities and develop products of

the highest quality, CTT, with the support of the Malaysian Government (through the Malaysian Technology Development Corporation/MTDC), has built a world-class state-of-the-ar t facility/laboratory for developing tissue-engineered products. The facility conforms to the current Good Manufacturing Practice (cGMP) regulations and is accredited by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health, Malaysia. Recognising quality and safety as critical in developing its products, the laboratory operates with reference to the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products under the Australian Government’s Therapeutic Goods Administration (TGA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products. CTT has consolidated all its Tissue Engineering manufacturing components, i.e., patented technology, state-of-the-ar t manufacturing facility, successful clinical trials, excellent quality control systems, and sufficient funding to be a true pioneer in this field.



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Exhibit 7: CTT’s cGMP Manufacturing Facility

Source: Cell Tissue Technology Sdn. Bhd. (CTT)

Products for Clinical Use

As one of the first laboratory engineered organs that matured for patient use, skin has generated a wide range of Tissue Engineering research in the public domain. Tissue engineered skin substitutes have been developed for wound healing and wound management of severe burns and acute and chronic wounds as well as aiding in plastic reconstructive surgeries and cosmetic surgeries. Due to the dear th of public information and research, skin substitutes are easier to replicate. Realising the potential of this field, CTT ventured to develop its own proprietary tissue engineered human skin, MyDerm®, an innovative one-of-its-kind product, that has taken more than 10 years to develop through extensive

R&D collaboration with UKM Medical Centre. It mimics natural skin to be an effective skin replacement for treating and managing severe burns, diabetic ulcers, chronic non–healing wounds, skin trauma and skin diseases. It is an autologous bilayer skin substitute, i.e., it comes from the patient’s own body and is completely compatible with the patient’s natural skin with no risk of immunological reaction or rejection. Exhibit 8 outlines the application process for MyDerm®. The process star ts with a biopsy sample taken from the patient. Cells from this skin biopsy are then isolated and cultured in CTT’s state-of-the ar t cGMP cer tified laboratory, developed into a regenerated skin which is then implanted onto the patient.



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Exhibit 8: MyDerm® Application Process Flow Diagram


While many companies have developed different therapies for skin grafting, only CTT has managed to develop an autologous skin equivalent, which uses cells from the same patient who requires the skin substitute. The other options in the market such as allograft skin (skin from other human sources or skin substitutes), autograft skin (healthy skin taken from another location on a person’s body) or synthetic skin cause pain, has a higher risk of rejection, and are semi-permanent, expensive, and not easily available.

Conventionally, the common treatment for burn victims is split skin grafting (SSG), where healthy or available skin is cut off from the patient’s unaffected body par t and grafted on the wound, which can be a very painful process. MyDerm® eliminates this unnecessary painful procedure and clinical trials have shown it to heal faster with lesser pain and less scarring, and in the long run, incur less dressing and lower cost. Exhibit 9 outlines its differences from other skin substitutes while Exhibit 10 summarises the advantages of MyDerm®.



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Exhibit 9: Comparison of MyDerm® with Other Skin Substitutes

Exhibit 10: Advantages of MyDerm®



MYDERM®

Identified as a human organ (skin)

Permanent skin substitute

Made of patient’s own cells and cell

derivatives

Provides organ replacement and systemic

treatment

Better prognosis, less long-term

maintenance

Identified as a medical device

Temporary skin substitute

Made from animal, external or synthetic sources

Provides external symptomatic treatment

Poorer prognosis, more long-term maintenance

OTHER SKIN SUBSTITUTES

NATURE

STRUCTURE

FUNCTION

OUTCOME

TECHNOLOGY

Autologous (fully patient’s own cells) – no rejection

Bilayered (full thickness) – looks almost like real skin

Protection, coverage, wound healing – acts almost like real skin

Lesser pain, faster wound closure, better outcome

Uses patented 3D Human Plasma Derivatives (HPD) biomaterial – behaves and responds like real skin



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Apart from MyDerm®, CTT’s innovative product line for clinical use includes:

• FibroDerm – bioengineered fibroblast construct for major skin loss and ulcers

• KeraDerm – bioengineered keratinocyte construct for major skin loss and ulcers

• CryoDerm – allogeneic cryopreserved skin construct for semi-permanent life-saving purposes

• SprayDerm – bioengineered skin cells for acute intervention in major skin loss

These products are variations of the MyDerm® technology, which can be used for different stages of clinical scenarios as they can potentially treat burns and wounds of varying severities. CTT’s technological capability and high-tech manufacturing facility position it to possibly develop other organs such as the bone, car tilage, and cornea in the future.

Products for Cosmetic Use

CTT has also ventured into the aesthetics/cosmetic market with its skin-based Tissue Engineering technology. It has developed Derm-Autologous™, a personalised aesthetics solution for rejuvenating ageing skin. The rising demand for more natural and safe products along with people’s obsession with youthful looks are some of the factors driving growth in the aesthetic/cosmetic domain.

Derm-Autologous™ is an anti-ageing autologous serum developed from fibroblasts, or collagen-producing cells, taken from a patient, cultivated, and reintroduced into the skin of the same patient. These cells are the natural producers of collagen and elastin, thus the product utilisation offers a more personalised skin rejuvenation therapy.

Derm-Autologous™ is revolutionary as it uses a person’s own cells. These fibroblast cells are expected to naturally and continuously produce the needed collagen and other growth factors crucial for maintaining the youthfulness of the patients’ skin. As people seek more personalised therapies, this miracle youth elixir is expected to be in more demand.

Products for Research/Industrial Use

CTT also provides research-grade 3D skin models, individual cells, and reconstructed tissues to support cell and tissue-based research by researchers or industries. For example, chronic wound-healing events occurring in humans are difficult to study in animals due to differences in skin physiology. Fur thermore, many countries are tightening restrictions in using animals for testing therapeutic properties of new compounds.

As animal models for research become more undesirable, CTT, using its Tissue Engineering capabilities has developed a tissue engineered human skin, Skin-in-a-Box™ to address the issue of animal models in the testing of safety and toxicity of compounds used in the cosmetics or other industries.

In fact, the product can also replace human skin testing, promising huge savings in clinical trial costs and time, as well as avoiding unnecessary complications/adverse reactions in living subjects.

This ar tificial skin enables the study of keratinocytes, melanocytes, fibroblasts, and endothelial cells, which are the residential cells that restore the skin’s main structural features.



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CTT, a Malaysian pioneer in the Tissue Engineering field, aims to become a regional and global player through its commitment to delivering innovative medical solutions that enhances and improves the quality of health for all. Through extensive R&D projects and a passion for new discoveries, the company has developed a range of safe and effective products that boost customer experience.

Apar t from its innovative MyDerm®, an autologous tissue engineered skin substitute proven for effective wound management, and its variations for different wound severities, Derm-Autologous™, a personalised aesthetics solution for rejuvenating ageing skin as well as research grade cells and tissue

to enable more research in the field, the company continues to conduct research on on-going projects and expand its portfolio.

CTT’s mission is to develop and brand Malaysia as a hub for Tissue Engineering activities in the region through its innovative solutions and technologies, and in the process make Tissue Engineering affordable and accessible to everyone. CTT is actively conducting fur ther on-going research and seeking research par tners and funders to fur ther its growth while building its client portfolio.

To learn more about CTT’s range of products and services, please visit http://www.cell-tissue.com.



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References

1. Frost & Sullivan, Human Tissue Engineering Market in Europ e - an Overview, April 19, 2012, http://www.frost.com/

q258919971.

2. Frost & Sullivan, Advances in Tissue Engineering, July 30, 2011, http://www.frost.com/d29f.

3. Frost & Sullivan, Advances in Tissue Engineering and Organ Regeneration: Technology Market Penetration and

Roadmapping, July 2013.

4. Frost & Sullivan, Technical Insights, Medical Devices, Technology Aler t, September 2015.

5. Frost & Sullivan, U.S. Tissue Engineering Markets, Jan 23, 2012, http://www.frost.com/n910.

6. MY DERM Booklet.

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nibib.nih.gov/science-education/science-topics/tissue-engineering-and-regenerative-medicine.

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and-regenerative-medicine/.

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grown-from-stem-cells-in-petri-dishes/.

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CELL TISSUE TECHNOLOGY SDN. BHD.

Cell Tissue Technology (CTT) is a Malaysian advanced medical technology-based company, a spin-off of the National University of

Malaysia (UKM), one of the country’s leading universities and research institutes. CTT aspires to not only becoming a world class

player in the Tissue Engineering field, but also as a corporate body with its own capacity to generate new discoveries, technologies

and knowledge through a wide range of research and study projects. CTT plans to establish as the industry mover and preferred

choice for the development, exploration and empowerment of Tissue Engineering and Regenerative Medicine in the country and

region beyond.

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tissue engineering · 2018-08-09 · tissue engineering: innovations in kin tissue engineering a...

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