Organs and tissue transplantations are the only curative therapy for major organ and tissue failures and loss, but are limited by the donor supply and often severe immune complications. Some of these obstacles may potentially be bypassed using cell-based regenerative therapy. Indeed, recent developments in the stem cell biology provided new hopes to heal or replace tissues and organs damaged due to congenital defects, ageing, disease, or trauma. The field of cell-based regenerative medicine encompasses numerous strategies, including the use of de-novo generated cell types from different stem cells as well as various combinations with other materials to repair or replace both structurally and functionally of the diseased organs. Despite the promising results from many pre-clinical studies, there are many major hurdles in the translation of cell-based regenerative therapy to the clinic. One of the major step to develop cell-based regenerative therapy is to achieve adequate safety and quality standards in manufacturing those products. In Hong Kong, current GMP guidelines and regulations are based on quality principles that have been established for pharmaceutical and healthcare manufacturers. Now the emergence of cell-based regenerative therapy raise new challenges, as manufacturing of cell-based products often deploys new biotechnological techniques like tissue engineering, genetic modification or sophisticated cell-culture techniques. Even more important is the fact that a product comprised of living cells or other fragile biological compounds cannot be standardised in the same way as a conventional pill. In this presentation, the future perspective to establish GMP cell-based therapy in Hong Kong will be discussed.
