Science, ethics and communication remain essential for the success of cell-based therapies
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 ran...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2016-01-01
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| Series: | Brain Circulation |
| Subjects: | |
| Online Access: | http://www.braincirculation.org/article.asp?issn=2394-8108;year=2016;volume=2;issue=3;spage=146;epage=151;aulast=Dominici |
| _version_ | 1811306889670033408 |
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| author | Massimo Dominici Karen M Nichols Aaron D Levine John EJ Rasko Miguel Forte Lynn O′Donnell Mickey BC Koh Catherine M Bollard Daniel J Weiss |
| author_facet | Massimo Dominici Karen M Nichols Aaron D Levine John EJ Rasko Miguel Forte Lynn O′Donnell Mickey BC Koh Catherine M Bollard Daniel J Weiss |
| author_sort | Massimo Dominici |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T08:53:35Z |
| format | Article |
| id | doaj.art-c1830ccc0e5a4196be6b978ce214a906 |
| institution | Directory Open Access Journal |
| issn | 2455-4626 |
| language | English |
| last_indexed | 2024-04-13T08:53:35Z |
| publishDate | 2016-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Brain Circulation |
| spelling | doaj.art-c1830ccc0e5a4196be6b978ce214a9062022-12-22T02:53:24ZengWolters Kluwer Medknow PublicationsBrain Circulation2455-46262016-01-012314615110.4103/2394-8108.192525Science, ethics and communication remain essential for the success of cell-based therapiesMassimo DominiciKaren M NicholsAaron D LevineJohn EJ RaskoMiguel ForteLynn O′DonnellMickey BC KohCatherine M BollardDaniel J WeissCell-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.http://www.braincirculation.org/article.asp?issn=2394-8108;year=2016;volume=2;issue=3;spage=146;epage=151;aulast=DominiciCommunicationinformed consentmedical tourismmesenchymal stem/stromal cellsregulationsstem cellsunproven cell therapies |
| spellingShingle | Massimo Dominici Karen M Nichols Aaron D Levine John EJ Rasko Miguel Forte Lynn O′Donnell Mickey BC Koh Catherine M Bollard Daniel J Weiss Science, ethics and communication remain essential for the success of cell-based therapies Brain Circulation Communication informed consent medical tourism mesenchymal stem/stromal cells regulations stem cells unproven cell therapies |
| title | Science, ethics and communication remain essential for the success of cell-based therapies |
| title_full | Science, ethics and communication remain essential for the success of cell-based therapies |
| title_fullStr | Science, ethics and communication remain essential for the success of cell-based therapies |
| title_full_unstemmed | Science, ethics and communication remain essential for the success of cell-based therapies |
| title_short | Science, ethics and communication remain essential for the success of cell-based therapies |
| title_sort | science ethics and communication remain essential for the success of cell based therapies |
| topic | Communication informed consent medical tourism mesenchymal stem/stromal cells regulations stem cells unproven cell therapies |
| url | http://www.braincirculation.org/article.asp?issn=2394-8108;year=2016;volume=2;issue=3;spage=146;epage=151;aulast=Dominici |
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