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Science, ethics and communication remain essential for the success of cell-based therapies
Massimo Dominici1, Karen M Nichols2, Aaron D Levine3, John EJ Rasko4, Miguel Forte5, Lynn O'Donnell6, Mickey BC Koh7, Catherine M Bollard8, Daniel J Weiss9
1 Laboratory of Cellular Therapy, University of Modena and Reggio Emilia, Modena, Italy
2 NantKwest, Inc., Woburn, MA, USA
3 School of Public Policy, Georgia Institute of Technology, Atlanta, GA, USA
4 Gene and Stem Cell Therapy Program, Centenary Institute, University of Sydney; Sydney Medical School, University of Sydney, NSW 2006; Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, Camperdown 2050, Australia
5 TxCell, Valbonne, France
6 Department of Internal Medicine, Division of Hematology, The Ohio State University, Columbus, OH, USA
7 Department of Haematology, St. George's Hospital, London, UK; Cell Therapy Program, Health Sciences Authority, Singapore
8 Center for Cancer and Immunology Research, Sheikh Zayed Institute, Children's National Health System, Washington, DC, USA
9 Department of Medicine, University of Vermont College of Medicine, Burlington, Vermont, USA
Correspondence Address:
Massimo Dominici
Laboratory of Cellular Therapy, University of Modena and Reggio Emilia, Via Del Pozzo, 71, Modena
Italy
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2394-8108.192525
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Cell-based therapeutics, such as marrow or peripheral blood stem cell transplantation, are a standard of care for certain malignancies. More recently, a wider variety of cell-based therapeutics including the use of mesenchymal stromal/stem cells, T-cells, and others show great promise in a wider range of diseases. With increased efforts to expand cell-based treatments to several clinical settings, many institutions around the world have developed programs to explore cellular therapy's potential for safe and effective applications. In legitimate investigations, usually conducted through academic centers or biotechnology industry-sponsored efforts, these studies are regulated and peer-reviewed to ensure safety and clear determination of potential efficacy. However, in some cases, the use of cell-based approaches is conducted with insufficient preclinical data, scientific rationale, and/or study plan for the diseases claimed to be treated, with patients being charged for these services without clear evidence of clinical benefit. In this context, patients may not be properly informed regarding the exact treatment they are receiving within a consenting process that may not be completely valid or ethical. Here, the authors emphasize the importance of distinguishing “proven cell-based therapies” from “unproven” and unauthorized cell-based therapies. This publication also addresses the necessity for improved communication between the different stakeholders in the field, patient associations, and advocacy groups in particular, to favor medical innovation and provide legitimate benefits to patients. Considering the progressive growth of cell-based treatments, their increasing therapeutic value and the expectation that society has about these therapies, it is critically important to protect patients and ensure that the risk/benefit ratio is favorable. This paper is a review article. Literature referred to in this paper has been listed in the references section. The datasets supporting the conclusions of this article are available online by searching PubMed. Some original points in this article come from the laboratory practice in our research centers and the authors' experiences. |
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