Regulation of an Emerging Medical Treatment

Caitlyn Reese, Fort Lewis College

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Abstract:In the past decade, scientific studies have shown that adult stem cells may have the potential to treat dozens of degenerative diseases and change the future of medicine. However, some private companies have preemptively begun using adult stem cells in unregulated human trials, and the FDA has been forced to shut down several facilities across the U.S. Regulation of this new biotechnology is necessary in the interest of public safety because there is not yet enough clinical evidence to support current use of adult stem cells.

Introduction Adult stem cells are defined as cells within a fully developed human tissue or organ that have not yet differentiated into cells with a specific function. The purpose of these cells in the body is to renew damaged or dead tissue where regeneration is continuously necessary, e.g., skin or blood. These cells have the potential to specialize into a desired function by artificial activation and subsequent implantation into a tissue where the cells can be influenced by surrounding functional cells.1 The discovery of stem cells as a potential medical treatment has invited the launch of many private companies in the U.S. within the past few years. These companies have since attempted to treat thousands of hopeful clients in so called “trials” for many illnesses including various types of blood cancer and other blood disorders, amyotrophic lateral sclerosis (ALS), type 1 diabetes, heart disease, COPD, Crohn’s disease, and many other degenerative disorders.2 However, the FDA stated that the cells used in the process were artificially manipulated and therefore need to be federally regulated as a drug. Controversy began after a federal law suit against Regenerative Sciences in Broomfield, Colorado, was settled in favor of the FDA in July of 2012.3 The court granted a permanent injunction against certain treatments offered by Regenerative Sciences, which has since opened the door for further inspections into the practices of several other companies.4 In the interest of public safety, regulation of this new biotechnology is necessary because it has not been scientifically proven that adult stem cell treatments are either effective or safe. This goes ignored by private companies in the interest of profit, which is unethical.

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