Optimizing Cell Culture Environments: Investigating Diffusive Properties of Granular Hydrogel Microfluidic Systems; Examining How Regulatory Science Culture Shapes the United States Federal Food and Drug Administration’s Regulation of Stem Cell Therapies

Swanekamp, Emily, School of Engineering and Applied Science, University of Virginia
Highley, Chris, Biomedical and Chemical Engineering, University of Virginia
Stafford, William, Engineering and Society, University of Virginia

The technical report details the development of a granular hydrogel microfluidic device (MFD) and the analysis of its diffusive properties in order to enhance the study of microvasculature formation. Currently, organoid research is limited because of the lack of vascularization and consequently the inefficient transfer of nutrients and gases. By constructing a MFD device out of a granular hydrogel material, researchers can improve the diffusive properties of microfluidics and better replicate the in vivo environment present during microvascular formation. This device provides an avenue to better understand the formation of microvasculature. Understanding the intricacies of microvascular formation is crucial for improving the integration of vascular networks within organoids which will allow for the comprehensive understanding of how tissue engineered constructs interact with complex microenvironments. Further optimization of microfluidic systems will facilitate researchers to generate more relevant models of human physiology and develop more effective methods for regenerating and repairing tissues.

My STS (Science, Technology, and Society) research paper is closely related to the possible tissue engineering applications of the MFD detailed in my technical report, however, it is focused on how regenerative medicine therapies are regulated by the Food and Drug Administration (FDA). In the United States (U.S.) the FDA oversees and approves of biological products for medical use. However, there has been a rise in clinics across the U.S. offering stem cell therapies that have not been FDA approved. One such case involved a stem cell therapy, aimed at treating a lung condition, that resulted in the death of Richard Pooling. In response to the increased reports of complications associated with these unregulated stem cell therapies, the FDA issued new guidances in 2017 detailing how they plan to regulate regenerative medicine therapies. Since the issuance of these new guidances, the FDA has begun litigation against certain clinics offering non-FDA approved stem cell therapies, such as California Stem Cell Treatment Center, Inc.

Stem cell therapies have the potential to be cutting edge medical treatments, but they can potentially be dangerous. Therefore, regulating stem cell therapies involves balancing scientific progress with patient safety. By investigating the origins of U.S. stem cell regulations, policymakers will be better informed to decide which stem cell regulations to adopt because it allows them to understand which policies can advance medical treatments while still ensuring patient’s safety. To that extent, I will apply the sociotechnical imaginaries framework to investigate how regulatory science culture shapes the FDA’s regulation of stem cell therapies. To achieve this, my STS research paper will offer a comprehensive overview of the FDA's regulatory framework governing stem cells and define the characteristics of regulatory science culture. Subsequently, my STS research paper will examine the court case of the United States of America v. California Stem Cell Treatment Center, Inc., which will shed light on how regulatory science as a culture shapes real-world regulatory practices, providing valuable insights into the FDA's decision-making process regarding stem cell therapies.

Looking at both of these reports together will highlight advancements in cell culturing techniques that have the potential to advance regenerative medical research and the origins of the FDA’s regulation of stem cell therapies. My technical project demonstrates the generation of a dynamic cell culturing environment through the successful fabrication of a granular hydrogel microfluidic device. On the other hand, my STS thesis investigates the influence of regulatory science culture on the FDA’s regulation of stem cell therapies, which could revolutionize these regulations so patients can receive safe and effective treatments in a timely manner.

Thank you to Professor Christopher Highley, Professor William Stafford, and Emily Ferrarese for their guidance and assistance during my technical project and STS research.

BS (Bachelor of Science)
Microfluidics, Granular Hydrogels, Vasculature, Food and Drug Administration, Regulatory Science Culture, Stem Cell Therapy Regulations
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