The emerging medical field of regenerative medicine poses exciting possibilities. Adult stem cells can potentially restore sight to the blind, help people overcome crippling conditions, and permit someone who is wheelchair-bound to walk again. These groundbreaking therapies are based on the fundamentals of molecular biology and have the potential to cure any disease resulting from damaged or malfunctioning cells, tissues, and organs in the human body. Tissues engineered from adult stem cells can replace and regenerate human cells to establish or restore normal functioning in organs damaged by genetic defects, trauma, disease, or aging.
Japan and the United Kingdom are pioneers in regenerative medicine. In the United States, the Food and Drug Administration (FDA) supervises these innovative treatments with an uncoordinated patchwork of regulations. There is a pressing need for a standardized approval process to ensure the systematic manufacturing, processing, control, and safety of these cutting-edge applications.
U.S. Senator Mark Steven Kirk (R-IL) took a step in the right direction in the Senate on March 16, 2016, by introducing the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness). This revolutionary legislation is designed to amend the Food, Drug, and Cosmetic Act with respect to cellular therapies in an effort to remove barriers to medical innovation and accelerate the development of regenerative medical treatments.
The REGROW Act will create an independent category for products in this field and protect approval pathways under the Public Health Service Act. The approval process for new therapies will be standardized. Initial conditional approvals will be granted for a period of five years, and the additional requirements for final approvals will be clearly outlined. The manufacturing, commerce, and use of these therapies will be regulated. Approval for biological therapies will be subject to demonstration of purity, potency, efficacy, and safety. Annual reports and reporting of adverse effects will be made mandatory. Cellular therapeutic devices will be classified based on their use, delivery, processing, and viability in the human body.
The REGROW Act is devised to collaborate with all the stakeholders—manufacturing companies, academic institutions, and regulatory organizations—to facilitate transparency and subject the manufacturing process of regenerative medicine products to regulatory predictability.
Amidst all this legal and congressional jargon, we cannot forget the human stories this legislation will impact. Vision recovery will become possible in people with macular degeneration, a leading cause of vision loss affecting more Americans than glaucoma and cataracts combined, previously considered incurable. This could potentially mean a man who lost his vision in his 30s could see his children for the first time. A woman with debilitating multiple sclerosis (MS) may be able to go into remission. A quadriplegic teenager who survived a car crash that left her with a severely damaged spinal cord may be able to walk again. The possibilities are endless.
Stem cell therapy is the only hope for millions of Americans facing devastating and deadly diseases. The REGROW Act is a long overdue legislation that will ensure patients receive bonafide therapies in regard to evidence-based medicine, while close regulations will ensure their efficacy and safety.
* Photo courtesy of http://www.kirk.senate.gov/