August 1, 2018 (Vol. 38, No. 14)

3D Approach Aims to Replace Human Tissue and Organs

Stratistics MRC ( reports that the global tissue engineering market is expected to grow from $7.06 billion in 2016 to $16.82 billion by 2023, with a CAGR of 13.2%. Growing usage of tissue engineering as an alternative for transplant organs is the major factor propelling the market’s growth.

In addition, recent technological advancements, government initiatives, and large investments in R&D are the some of the key factors fostering the market’s growth. On the other hand, strict regulations for approvals, long timelines for tissue development, and high costs are the constraints limiting the market’s growth, say company officials.

Among all the applications, the orthopedic segment leads the market globally with the biggest market share and is expected to grow with a higher CAGR during the forecast period, notes the report. The growth of this segment is attributed to a growing geriatric population and rising incidence of reconstructive and replacement surgeries.

The neurology segment is also likely to grow at a faster-than-average rate due to increasing R&D investments. The report continues that North America has emerged as the major revenue-generating region in the global market due to both innovative technological developments and the increasing incidence of cancer in the Canada and U.S. The Asia Pacific region is likewise expected to witness a high rate of growth during the forecast period.

According to the report, major applications for tissue engineering include: orthopedics, musculoskeletal and spine, cardiology and vascular, neurology, dental, cord blood and cell banking, gastrointestinal, gynecology, skin/integumentary, urology, and cancer.

Significant Advances

To find out about recent significant advances in the field over the past year, GEN interviewed key editorial members of Tissue Engineering Parts A, B, and C, journals published by Mary Ann Liebert, Inc. These included co-editors-in-chief Antonios G. Mikos, Ph.D., and John P. Fisher, Ph.D., and methods co-editor-in-chief (Part C) John A. Jansen, DDS, Ph.D.

Dr. Mikos: Integra LifeSciences’ OmnigraftTM is a dermal regeneration template that was first approved by the FDA in 1996 for use as a skin graft following life-threatening burn injuries. In January of 2016, Omnigraft received FDA approval for use with standard diabetic ulcer care in the treatment of diabetic foot ulcers that persist for longer than six weeks.

Vericel’s MACI® (autologous cultured chondrocytes on porcine collagen membrane) for the treatment of osteochondral defects was approved by the FDA in December of 2016, following a two-year Phase III clinical trial that validated its safety and efficacy compared to traditional microfracture technique. MACI is the first FDA-approved tissue engineering product that combines scaffolds and autologous cells from the patient.

Antonios G. Mikos, Ph.D.

Dr. Fisher: Stryker’s Tritanium® TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage, received 510(k) clearance from the FDA in January of 2018. The intervertebral body fusion device is indicated for use with autograft and/or allogenic bone graft as an aid in lumbar fixation for patients with degenerative disc disease (DDD).

Organovo’s NovoTissue®, a 3D-bioprinted liver therapeutic tissue used for the treatment of alpha-1 antitrypsin deficiency (A1AT) was granted orphan drug designation by the FDA in December 2017. The artificial 3D-printed tissue will be used as a drug testing platform, and the company plans to file an IND with the FDA by 2020.

OssDsign’s OSSDSIGN® Cranial PSI, a 3D-printed medical implant intended for reconstruction of cranial defects received 510(k) clearance from the FDA in January 2017. The implant is patient-specific and used for facial and cranial reconstruction after cranioplasty. The implant is 3D printed from a proprietary calcium phosphate composite and reinforced by a titanium skeleton.

Aprecia Pharmaceuticals’ Spritam® (levetiracetam) is a prescription drug product manufactured via 3D-printing technology. In July of 2015, it became the first such drug to be approved by the FDA. 3D-printed Spritam tablets, which became commercially available in March of 2016, are designed for rapid disintegration upon consumption. They are used in the treatment of epileptic seizures.

John P. Fisher, Ph.D.

Dr. Jansen: Developments in organoid cultures provide the possibility of developing nature-like engineered structures that can be used, e.g., for drug testing and will reduce the need/use of experimental animals.

Exosomes (ECs) are cell-derived vesicles, which contain biomolecules. ECs can be applied to regenerate damaged tissue, e.g., by local application injection.

Recent advances in 3D printing provide the possibility to build complex tissues from cells combined with a scaffold material.

Tissue-engineered heart vesicles are heart valves grown in specially designed bioreactors and are composed of biological materials. The use of these tissue-engineered heart valves is now close to human clinical trials.

CRISPR-Cas genome editing can be used to modify cells to make them more potent for application in tissue engineering.

John A. Jansen, Ph.D., DDS

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