Challenging the FDA's authority to regulate autologous adult stem cells for therapeutic use: Celltex Therapeutics' partnership with RNL Bio, substantial medical risks, and the implications of United States v. Regenerative Sciences.

Author:Drabiak-Syed, Katherine
 
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ABSTRACT

This Article examines the convergence of three corporations that have attempted to capitalize on translating emerging research into clinical procedures by manufacturing and facilitating the process for patients to obtain mesenchymal stem cell (MSC) injections. Although the Food and Drug Administration (FDA) has asserted its authority to regulate somatic cell therapy products like MSCs under the Public Health Service Act and the Food, Drug, and Cosmetic Act, some manufacturers have attempted to circumvent FDA regulation through various mechanisms and argue that their products do not fall within the definition of a biological product or drug. However, scientific knowledge of using MSCs for clinical therapy remains in its infancy, and MSCs pose a number of serious risks to patients. This Article focuses on the development of Celltex, a company based in Sugar Land, Texas that manufactures and facilitates the injection of autologous MSCs; RNL Bio, a company that licenses its operations technology to Celltex; and Regenerative Sciences, a company based in Broomfield, Colorado that was recently involved in litigation with the FDA. Corporate circumvention of intended regulatory oversight exposes patients to potentially inefficacious products that could contribute to serious medical injuries such as viruses, myocardial infarction, cancer, or death.

CONTENTS INTRODUCTION I. THE RISE OF ASCs IN TEXAS: DR. STANLEY JONES, GOV. RICK PERRY, CELLTEX THERAPEUTICS, AND RNL BIO II. FDA REGULATION OF ASCs A. Regulation of Human Cell and Tissue Products (HCT/Ps) B. Regulation under the PHSA and the FDCA C. FDA Guidance and Application to ASCs III. RISKS OF ASCs IN SCIENTIFIC LITERATURE IV. CELLTEX THERAPEUTICS A. Red Flag: Professor Turner's Letter to the FDA B. FDA Inspection of Celltex C. Celltex Prepares to Challenge the FDA V. RNL, STEM CELL TOURISM, AND LEE V. HUMAN BIOSTAR A. RNL Bio: Seoul, Korea B. RNL Life Sciences: Los Angeles, California C. Lee v. Human Biostar D. Celltex's Adoption of RNL's Business Model VI. THE FDA's AUTHORITY TO REGULATE MSCs AS BIOLOGICAL PRODUCTS AND DRUGS IN UNITED STATES V. REGENERATIVE SCIENCES VII. IMPLICATIONS FOR CELLTEX AND PHYSICIANS A. Celltex's Position B. Texas Medical Board Rules C. Physician Duty and Texas State Law 1. Ethical Duties and the Purpose of the State Medical Board 2. Professional Sanction or Liability for Physicians Performing Injections D. FDA 's Enforcement Action: Warning Letter to Celltex CONCLUSION INTRODUCTION

Over the past few years, a growing number of companies have started to offer patients purported treatment for various diseases and conditions using autologous adult stem cells (ACSs) for non-homologous purposes--specifically mesenchymal stem cells (MSCs) derived from the patient's own adipose tissue. (1) This Article examines the convergence of three corporations that have attempted to capitalize on translating emerging research into clinical procedures by manufacturing and facilitating the process for patients to obtain mesenchymal stem cell (MSC) injections. (2) The FDA has asserted its authority to regulate somatic cell therapy products, including MSCs, under the Public Health Service Act (PHSA) and the Food, Drug, and Cosmetic Act (FDCA), but some manufacturers have attempted to circumvent FDA regulations through various strategies--namely, by arguing that their products do not fall within the definition of a "drug" so the corporation need not follow the requirements set forth in the FDCA prior to advertising the product for treatment purposes. This Article examines: (1) the development of Celltex, a company that manufactures and facilitates the injection of autologous MSCs; (2) RNL Bio, the company that licenses its operations technology to Celltex; and (3) recent litigation between the FDA and Regenerative Sciences.

ASCs are unspecialized multi-potent cells that are capable of renewing themselves through cell division and differentiating into different types of cells, (3) Unlike pluripotent cells, which are capable of differentiating into all tissues of the patient, ASCs are more limited in their ability to differentiate. (4) They can be derived through sources such as bone marrow, muscle, skin, and teeth; more recently, scientists have begun extracting and isolating them from adipose tissue. (5) Despite ASCs' anticipated potential for clinical therapies, the scientific community is just beginning to understand their efficacy and safety. (6) In addition to uncertain benefit, the manipulation and injection of stem cells poses a number of risks arising from inherent properties of the cells and the method of manufacture.

Part I of this Article describes the development of Celltex and its connection to Texas Governor Rick Perry and outspoken physician and Celltex co-founder Dr. Stanley Jones. This section explores Celltex's connection to RNL Bio and describes the initial media coverage relating to Celltex's practices. Part II provides an overview of sections of the PHSA and the FDCA pertaining to the manufacture of MSCs and describes FDA guidance that explicitly states the agency's intention to regulate MSCs and adipose stem cells as somatic cell therapy products within the framework of biological products and drugs. Part III discusses the current scientific research examining potential clinical uses of ASCs and summarizes the numerous and potentially severe risks associated with autologous ASC injections for non-homologous use, where the injected stein cells are intended to differentiate and restore and repair other areas of the brain or body. Part IV provides an overview of Celltex's business practices and product claims. It discusses concerns raised by bioethicists and the media and also describes the FDA's recent findings during a facility inspection. Part V describes why Celltex's business arrangement with RNL Bio raises additional concerns and summarizes allegations against the company's subsidiary as set forth in a recent lawsuit connected to the subsidiary's business practices in Los Angeles, California. Part VI summarizes recent litigation in which the FDA asserted its authority under the PHSA and the FDCA to regulate Regenerative Sciences' practices of manufacturing and facilitating the injection of MSCs to patients. This non-binding precedent is significant because it affirms that the FDA has appropriately set forth regulations to classify types of ASCs and has the authority to regulate MSCs under the PHSA and the FDCA. Finally, Part VII explores the implications for physicians performing the injections and examines regulations set forth by the Texas Medical Board, professional standards, and Texas state law.

  1. THE RISE OF ASCs IN TEXAS: DR. STANLEY JONES, Gov. RICK PERRY, CELLTEX THERAPEUTICS, AND RNL BIO

    In the past few years, both local and national media have reported on the development of initiatives to advance ASCs for treatment purposes in Texas. In May 2010, an orthopedic surgeon named Dr. Stanley Jones traveled with his wife, Kathi Jones, a registered nurse and owner of a medical spa, to Kyoto, Japan to undergo ASC infusions administered by RNL Bio, a company based in Seoul, South Korea. (7) Five months later, the company reported in a press release that Dr. Jones experienced complete recovery from his autoimmune arthritis. (8)

    Jones, a personal friend of Texas Governor Rick Perry, stated that he felt compelled and "moved by his faith" to call on Perry for his support to permit commercializing ASC procedures in Texas. (9) In addition to the close relationship between Jones and Perry, Celltex cofounder David Eller contributed a substantial amount to Perry's election campaign. (10) In July 2011, Texas newspapers and online media outlets widely reported that Jones performed an infusion of autologous MSCs by injecting the cells into Perry's back and bloodstream as a treatment for Perry's existing back injury. (11) Weeks after Perry received the injections, he contacted the Texas Medical Board (the Board) at Jones' behest, requesting that it promulgate rules to ensure that physicians would be permitted to perform stem cell infusions. (12) Around the same time, Texas State Representative Rick Hardcastle, who also received MSC infusions from Jones, sent a letter to the Board. A month prior to Perry's injection in the summer of 2011, Rep. Hardcastle introduced legislation to create a stem cell bank in the state and wrote to the Board that he did not intend to create "onerous and unnecessary regulations to impede the practice and research of physicians in regards to the use of investigational agents." (13)

    The amount of publicity around Perry's injections attracted the attention of Nature, which began publishing articles on the use of ASCs in Texas and FDA regulations relating to the practice. Perry continued to publicly acclaim his infusions and expressed his hope that "Texas [would] become the world's leader in the research and use of adult stem cells" and "lead the nation in advancing adult-stem-cell research that will treat diseases, cure cancers, and ultimately, save lives." (14) Despite Perry's claims, Nature reiterated that the FDA has not approved such ASC treatments because it regulates cells that undergo more than minimal manipulation during the cell culturing process, (15) In the past few years, manufacturers and clinics in the United States have begun circumventing FDA regulations in various ways: by sending patients overseas for the injections (RNL Bio and RNL Life Sciences); asserting that the manufacture and injection of ASCs falls within the practice of medicine (Regenerative Sciences and Stanley Jones); or arguing that MSCs do not fall within the regulatory definition of "drugs" overseen by the FDA (Regenerative Science and Celltex). (16) Specifically, manufacturers such as Celltex argue that the process of culturing and preparing the stem cells does not constitute the manufacture of a biological drug, so...

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