Imagine you are experiencing heart failure after suffering from hypertrophic cardiomyopathy. Or perhaps you need a kidney donation after battling chronic kidney disease for many years. In either case, you have become one of more than 100,000 people waiting for an organ transplant. There’s nothing you can do but wait for a donor, and given that there are more than eight times as many people on organ waiting lists than there are donors, you’re most likely in for a long wait.
But soon that may no longer be the case. Stem cell therapy has been thrown around as a potential solution to the organ shortage for many years. Unlike regular adult cells, stem cells have the potential to grow and differentiate into a wide range of cell types. When grown on specialized scaffolding, they arrange themselves into tissues. Rather than waiting for a donor’s kidney, a new kidney could be grown.
Unfortunately, because it traditionally uses cells taken from embryos, the field of stem cell research has been shrouded in controversy. This all changed in 2006 when Dr. Shinya Yamanaka’s team at Kyoto University used adult skin cells to generate stem cells called induced pluripotent stem cells (iPSCs). Suddenly, a whole new field of research opened up. Not only do these cells bypass the ethical questions raised by using embryonic cells, but they also come with the added benefit of having been taken from the patients themselves. Normally, organ transplant recipients must take drugs that suppress their immune systems for the rest of their lives so that their bodies do not reject the foreign tissue. However, organs created using iPSCs would be genetically identical to the patient’s own cells.
Since the advent of iPSCs, scientists have used them to create a diverse array of tissues, from heart cells to liver buds that functioned when implanted into mice. One of the last remaining obstacles to providing therapies based on these cells is the process of manufacturing. Currently the process is too time- and labor-intensive to be feasibly implemented on a large scale. Furthermore, a standardized manufacturing process that guarantees the safety of the treatment must be developed before the U.S. Food and Drug Administration can approve it.
Tough as they seem, there might be a solution to the problems of manufacturing and regulatory approval. Large collections of human cells, called iPSC banks, could provide a diverse range of iPSC lines that are genetically matched to large segments of the population. While the more individualized approach is ideal from the perspective of avoiding immune rejection, iPSC banks would streamline the process and benefit from economies of scale. In fact, it has been estimated that they could save between $50,000 and $100,000 and six months of time per patient.
These banks would also have the resources to oversee the treatment process from start to finish and to provide a more standardized procedure. Oversight and standardization are key because the FDA must be satisfied that the entire process is safe before granting approval. This is difficult currently because of the potential risks in the complex process of growing cells in academic laboratories before transferring them to clinical facilities. Indeed, the creation of iPSC banks is a promising step in the journey towards the ability to synthesize organs — one that is increasingly important as the number of people on organ donation waiting lists continues to grow.
Gloria Wu is a freshman in Timothy Dwight College. Contact her at email@example.com.
(Featured image from Wikimedia.)