Author: Dar-Jen Hsieh, CEO of ACRO Biomedical Co., Ltd.
Regenerative Medicine has been the spotlight of international biotechnology events in recent years. The governments of advanced countries have actively invested huge funds and talents into this popular field. Venture capital around the world is also pouring into the field of Tissue Engineering and Regenerative Medicine (TERM), thus creating an investment trend.
What is Regenerative Medicine? As the name suggests, it is a medical method that allows damaged tissues and organs in the body to be repaired and regenerated. According to the National Institute of Health, Regenerative Medicine is a broad field that includes tissue engineering but also incorporates research on self-healing – where the body uses its own systems, sometimes with the help of foreign biological materials, to recreate cells and rebuild tissues and organs. The ultimate goal of Regenerative Medicine is to completely heal the damaged tissues and organs of patients rather than simply treating the symptoms of the disease.
There are three key elements in TERM, the cells, the scaffolds, and the signals. "Cells" refer to stem cells or any somatic cells with the function of tissue repairing. "Scaffolds" in our body refer to the natural collagen scaffolds for cell attachment and proliferation. And "signals" refer to the growth factors, cytokines or any signaling molecules present in the blood circulation, that are capable of stimulating cell growth, cell differentiation, and tissue repairing. With the combination of these three elements, almost all damaged tissues and organs can be regenerated and repaired.
When tissues or organs are damaged, the native collagen scaffolds are impaired as well. Providing a proper collagen scaffold in time of need can facilitate the tissue regeneration process. With the proper decellularization technology, native collagen scaffolds derived from decellularized porcine tissues and organs have excellent biocompatibility and can repair damaged human tissues rapidly; the problem of host immune rejection is also minimized. The hope for decellularized collagen scaffolds to replace human donated organs is very promising since the materials for producing the collagen scaffolds are everywhere, and there's no need for the patients to wait in line.
The porcine-derived biomaterials include artificial skin, bone graft, cartilage graft, cornea, arterial blood vessel, peripheral nerve, spinal nerve, trachea, ureter, heart, kidney, liver, etc. In the near future, the entire medical procedure will be subverted. There won't be any need for autografts and organ transplantations.
As the patient's age increases, the ability of the "cells" and "signals" in the body to regenerate tissues and organs also gradually declines. Therefore, the treatment for the elderly usually includes a native collagen scaffold, foreign stem cells, and "signals" with various nutrients; making the treatment of damaged tissues and organs more effective.
The Ministry of Health and Welfare in Taiwan amended the "Regulations Governing Implementation or Use of Specific Medical Technology, Examination, Laboratory Testing and Medical Devices" on September 6, 2018. Six items of cellular therapy deemed with ascertain safety and expectable efficacy were listed. This new regulation is expected to have a significant impact on the development of cellular therapies in Taiwan. The progress of regenerative medicine is expected to accelerate. How to correctly and effectively combine the three elements of tissue engineering to customize medical treatments for patients will be the most important subject of the biotech industry, and also a very popular investment trend.
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