ABSTRACT
BACKGROUND: Unproven cellular therapies are being offered to patients for a variety of conditions and diseases for which other treatments have failed. The use of untested cellular therapies is a worldwide problem. Practitioners (e.g., physicians, scientists, QA/QI facility managers, and policy advocates) are perhaps unaware of the risks involved with such therapies. Therefore, a critical need exists to bring attention to the potential limitations and adverse effects of these therapies to inform and limit misinformation. STUDY DESIGN AND METHODS: We describe the extent of the unproven cellular therapy problem through a search of scientific literature and social media coverage. We also describe the regulatory framework that can be used by the practitioner to review and evaluate both proven and unproven cellular therapies. RESULTS: We report on the current state of unproven cellular therapies across the globe. A workflow to facilitate an understanding of the regulatory processes involved in the approval of cellular therapies is provided as well as a list of warnings required by regulatory agencies on various products. It is hoped that this article will serve as a tool kit to educate the practitioner on navigating the field of unproven cellular therapy products. DISCUSSION: Increasing awareness of the issues associated with unproven therapies through education is important to help in reducing misinformation and risks to patients.
Subject(s)
Cell- and Tissue-Based Therapy , Physicians , Cell- and Tissue-Based Therapy/adverse effects , HumansABSTRACT
As the field of embryonic stem cell culture and differentiation advances, many diverse culturing techniques will ultimately be necessary in order to fully reproduce the various environments these cells normally encounter during development. Although most of the work to date has been performed on solid plastic supports, this growth support has several limitations in its representation of the in vivo environment. Impermeable substrates force the cells to exchange their gas and nutrients exclusively through the top side of the cultured cells. In contrast, cells growing in vivo are exposed from several directions to factors from the blood, other cells, soluble factors, and liquid-air interfaces. Additionally, solid plastic presents a smooth two-dimensional surface that is not experienced in vivo. Therefore, the use of traditional plastic presents limitations upon normal cellular morphology, function, and differentiation. An important alternative to growth on solid plastic is the growth of cells on microporous membranes. One of the many advantages to cell growth on porous membrane substrates is their ability to provide a surface that better mimics a three-dimensional in vivo setting. A porous membrane allows multidirectional exposure to nutrients and waste products. In addition, the membrane separation of dual chambers allows for the coculture of cells of different origin to study how cells interact through indirect signaling or through providing a conditioned niche for the proper growth and differentiation of cell types.
