Tissue Engineering and Regenerative Medicine
2018年3月28天 Dr Nadia Tsao
The aim of tissue engineering and regenerative medicine is to create living biological tissue that can repair and replace damaged tissues in the body, something that cannot be achieved by medicine and medical procedures. IDTechEx have already published a market research report (Tissue Engineering 2018-2028: Technologies, Markets, Forecasts) on this topic, and will be holding a masterclass at 3.30pm on April 10th 2018 at the Estrel Convention Center in Berlin, Germany. The masterclass will cover the many applications of engineered tissues, as well as provide an overview of the wide range of techniques and technologies that can be used to fabricate living biological structures.
To date, there are only a couple of FDA-approved tissue engineered therapies available. One of the latest therapies to be approved is MACI (Vericel). MACI is a bioengineered construct consisting of a patient's own cartilage cells (autologous chondrocytes) cultured on a porcine collagen membrane. To create MACI, a patient's healthy cells are first collected through an arthroscopic procedure. The biopsy is sent to Vericel's laboratory for processing and isolation of the chondrocyte cells. These chondrocytes are then uniformly seeded onto a bioresorbable collagen scaffold, where they are grown until a high cell density has been reached. This cell-laden scaffold is then sent from the laboratory to the hospital, where a surgeon will implant it into the patient. MACI was approved in December 2016 by the FDA for the treatment of cartilage defects of the knee.
Vericel, the leading tissue engineering and regenerative medicine company that manufactures MACI, has recently published the results of the extension to their Phase III clinical trial (the SUMMIT trial). The 5-year post-treatment follow-up shows that MACI still provides superior patient improvement in pain and function versus its comparator, microfracture. Microfracture is the current standard of care for the treatment of cartilage defects. It is a surgical procedure in which tiny fractures are created in the underlying bone in the knee in a bid to recruit stem cells from within the bone marrow to the site of cartilage damage. MACI remains the only cartilage implant to show superiority to microfracture in a Phase III randomized controlled trial at 2-years post-treatment as defined by the Knee Injury and Osteoarthritis Outcome Score (KOOS). This extension study brings the total time of superior improvement of MACI over microfracture to 5 years post-transplant.
Although bioengineered cartilage has been used to treat thousands of patients around the world for almost 2 decades, this is the first time that durable superiority of a bioengineered implant has been shown through a long-term follow-up of a randomized controlled trial. This body of high-level evidence in favor of tissue engineered cartilage is expected to grow - currently TETEC and Histogenics are conducting Phase III randomized controlled trials in the US for the commercialization of cartilage constructs Novocart 3D and NeoCart respectively.
Top image: Wikipedia