Review Article

Stem Cells and Tissue Engineering in Medical Practice: Ethical and Regulatory Policies

Author(s): Rakesh Sharma*

Volume 20, Issue 4, 2019

Page: [388 - 398] Pages: 11

DOI: 10.2174/1389450119666180831095830

Price: $65


Stem Cell Research and Tissue Engineering, in present time, have emerged as a legalized and regulated stem cell treatment option globally, but scientifically, their success is unestablished. Novel stem cell-based therapies have evolved as innovative and routine clinical solutions by commercial companies and hospitals across the world. Such rampant spread of stem cell clinics throughout UK, US, Europe and Asia reflect the public encouragement of benefits to incurable diseases. However, ever growing stem cell therapy developments need constant dogwatch and careful policy making by government regulatory bodies for prompt action in case of any untoward public concern. Therefore, researchers and physicians must keep themselves abreast of current knowledge on stem cells, tissue engineering devices in treatment and its safe legal limits. With this aim, stem cell scienctific developments, treatment options and legal scenario are introduced here to beginner or actively inolved scientists and physicians. Introduction to stem cell therapy will provide basic information to beginner researchers and practice physicians on engineered stem cell research concepts and present stem cell therapy federal regulations in different North American, European and Asian countries. FDA, CDC, EU, ICMR government policies in different countries include information on the current legal position, ethical policies, regulatory oversight and relevant laws.

Keywords: Pluripotent stem cells, stem cell medical practice, tissue engineering, stem cell therapy, stem cell legal status, government guidelines, regulatory polices.

Graphical Abstract
Ratajczak MZ, Kucia M, Jadczyk T, et al. Pivotal role of paracrine effects in stem cell therapies in regenerative medicine: Can we translate stem cell-secreted paracrine factors and microvesicles into better therapeutic strategies? Leukemia 2012; 26(6): 1166-73.
European Commission, Community Research and Development Information Service: Available from:. en.html
European Commission, International Cooperation and Development:.
Fortpflanzungsmedizingesetz geändert wird (Fortpflanzungsmedizingesetz- Novelle 2004 – FMedGNov 2004), Reproductive Medicine Act Amendment 2004 – FmedGNov 2004: Available from:. http:// Dokumentnummer= BGBLA_ 2004_I_163 ,
‘Research on human embryonic stem research’ Opinion of the Austrian Bioethics Commission, 16 March 2009, Bunderkanzleramt Österriech, Austrian Bioethics Commission:. site/3575/default.aspx
‘Ethical aspects of the development and use of assistive technologies’, Opinion of the Austrian Bioethics Commission, 13 July 2009, Bunderkanzleramt Österriech, Austrian Bioethics Commission:.
‘Collecting stem cells from umbilical cord blood’, Ruling of the Bioethics Commission, 16 March 2009, Bunderkanzleramt Österriech, Austrian Bioethics..
The Health Act (Promulgated in the State Gazette, issue No. 70/10 August 2004, entered into force on 1 January 2005):.
Regulation on the terms and conditions of activity of the central ethics commission under the Council of Ministers in accordance with the Law of Medicinal Products in Human Medicine (adopted 28 September 2007, SG 81/0 October 2007):. ldoc/2135566887
Bulgarian Centre for Bioethics:. content/mission
Act on Research on Human Embryonic Stem Cells and Related Activities and on Amendment to Some Related Acts, Zákon o výzkumu na lidských embryonálních kmenových buňkách a souvisejících činností a na Změně některých souvisejících zákonů:.
Bioethical Commission of the Czech Research and Development Council:.
Act on Medical Research (9.4.1999/488), Laki lääketieteellisestä tutkimuksesta (9.4.1999/488) Suomi:. alkup/1999/19990488
Finnish National Ethics Committee report 2006, Opinion on EU research funding on stem cells.http;// en/ materials/opinions/2006
The Act on the Medical Use of Organs and Tissues (2.2.2001/101), Laki lääketieteellisestä käytöstä elimien ja kudoksien (2.2.2001/101).
Law on Bioethics, Law n. 2004-800 of 6 August 2004 (Loi n. 2004- 800 du 6 Août 2004 relative à la bioéthique):. research/biosociety/pdf/french_law.pdf andhttp://www.legifrance. Texte
French ConstCouncil, 27 July 1994, 94-343-344 DC:. http://
Act ensuring Protection of Embryos in connection with the importation and use of human embryonic stem cells, Gesetz zur Sicherstellung des Embryonenschutzes im Zusammenhang mit Einfuhr und Verwendung menschlicher embryonaler Stammzellen Stammzellgesetz (StZG- Stem Cell Act), 14 August 2008:.
Central Ethics Commission for Stem Cell Research [Zentrale Ethik- Kommission für Stammzellenforschung - ZES. https://
Law on the Transplantation of Organs, Tissues and Cells (Promulgated in the State Gazette, issue No. 83/19 September 2003, entered into force on 1 January 2004), Available from:.
Bioethical Commission of the Czech Research and Development Council, Available from:.
Finnish National Ethics Committee, "Opinion on EU research funding on stem cells "The Act on the Medical Use of Organs and Tissues (2.2.2001/101), Laki lääketieteellisestä käytöstä elimien ja kudoksien (2.2.2001/101), Available from:. laki/alkup/ 2001/20010102
Law 3305/2005 on Medically assisted reproduction techniques, Official Gazette of the Hellenic Republic, 27 January 2005, Νόμος 3305/2005 για την ιατρικώς υποβοηθούμενης αναπαραγωγής (ΦΕΚ Α΄17 27.1.2005) Available from:.
Hellenic National Bioethics Commission, "Report on the use of stem cells in biomedical research and clinical medicine", Available from:. eng.pdf
Irish Stem Cell Research Foundation, Irish Public Policy and Human Embryonic Stem Cell Research, Irish Stem Cell Research Foundation, April 2010, Available from:. http://
Law on Ethics of Biomedical Research No.VIII-1679 of 11 May 2000 (last amended on 15 November 2007 – No. X-1325), available Available from:. showdoc_ l?p_id=326057
Lithuanian Bioethics Committee (LBC), Available from:.
Law No. 32/2006 of 26 July on medically assisted procreation [Lei no. 32/2006 Procriação medicamente assistida de 26 de Joelho], Available from:. 4022.pdf
47/CNECV/05, Opinion Nº 47: ‘Opinion on Stem Cell Research’, Conselho Nacional de Ética para as Ciências da Vida (CNECV),The National Council of Ethics for the Life Sciences, Available from:.
Law on Biomedical Research 14/2007 of July 3, Ley 14/2007, de 3 de julio, de Investigación biomedical, Madrid: Boletín Oficial del Estado, Available from:. pdfs/A28826-28848.pdf
Guarantees Commission for the Donation and Use of Human Cells and Tissues, established under the following law: Real Decreto 1527/2010, de 15 de noviembre, por el que se regulan la Comisión de Garantías para la Donación y Utilización de Células y Tejidos Humanos y el Registro de Proyectos de Investigación. Available from:.
Opinion on a preliminary law proposal regulating stem cell research, 2003-05-20, Statins Medinksa -Etisk Rad, Swedish National Council of Bioethics, Available from:. http://
House of Lords Select Committee on Stem Cell Research (2002), Available from:. pa/ld200102/ldselect/ldstem/83/8301.htm
21CFR Part 1271- Human cells, tissues, and cellular and tissue based products. Cornell University document.. https://
Human Tissue Act 2004, Available from:. http://
Human Fertilisation and Embryology (Research Purposes) Regulations 2001:. uksi_20010188_en.pdf
Law JX, Liau LL, Aminuddin BS, Ruszymah BH. Tissue-engineered trachea: A review. Int J Pediatr Otorhinolaryngol 2016; 91: 55-63.
Stem Cell Therapies: 4. Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary. Board on Health Sciences Policy; Board on Life Sciences; Division on Earth and Life Studies; Institute of Medicine; National Academy of Sciences.Washington (DC): National Academies Press (US); 2014.
Yamanaka S. Induction of pluripotent stem cells from mouse fibroblasts by four transcription factors. Cell Prolif 2008; 41(Suppl. 1): S51-6.

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