Stem Cell Technology Will Provide Revolutionary Treatments for Diseases
As stem cell technology has the ability to regenerate complex tissue of all types, it offers scope for revolutionary treatments for diseases that currently have no cure to be developed, according to GlobalData, a leading data and analytics company.
Many companies are looking to monetize these cells for a variety of serious ailments, but the efficacy and safety of stem cell technology remain questionable. Regulatory bodies are therefore seeking to modernize product licensing pathways to ensure the continued efficacy and safety of available stem cell treatments. The FDA recently released new guidelines to bring regenerative medicine advanced therapies (RMATs) under tighter regulation, in the hope of striking a balance between safety concerns and therapy innovation.
David Brown, PhD, Healthcare Analyst at GlobalData, comments: “Stem cells hold the incredible potential to treat currently untreatable diseases, such as age-related macular degeneration (AMD), a leading cause of vision loss in those over 50. Several studies have demonstrated that stem cell-derived retinal pigmented epithelial cells can safely integrate into the patient’s retina, and improve sight after transplantation.”
As this technology holds the promise to treat diseases for which there are currently no treatments, it is unsurprising that private interests have begun to enter the stem cell space. As stem cell therapies differ from traditional drug-based therapies, a gap has formed between the regulatory bodies, such as the FDA, and stem cell-based products. This has led to the proliferation of unregulated and unproven stem cell therapies.
Brown notes: “In an effort to address this issue, the FDA has begun issuing warning letters to companies that it deems to be overstepping the bounds of developing and delivering safe and effective therapies. In addition, it has released a framework to define and guide the approval process of RMATs, seeking to balance the need for safe and effective treatments with the ability to innovate in the stem cell therapy space.
The framework states that stem cell-derived products that are minimally altered and are used for the same purpose in both donor and host do not need premarket approval, and are subject only to regulations that prevent the transmission of communicable diseases. Products that do not fall under this umbrella, however, are regulated as drugs, biologics, or devices.
Brown concludes: “As the gaps between new stem cell therapies and regulatory bodies are bridged, we expect that new and exciting therapeutic options will become available, and their subsequent markets will open up.”
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