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Lancet Commission: Stem cells and regenerative medicine

Cossu, Giulio ; Birchall, Martin ; Brown, Tracey ; De Coppi, Paolo ; Culme-Seymour, Emily ; Gibbon, Sahra ; Hitchcock, Julian ; Mason, Chris ; Montgomery, Jonathan ; Morris, Steve ; Muntoni, Francesco ; Napier, David ; Owji, Nazanin ; Prasad, Aarathi ; Round, Jeff ; Saprai, Prince ; Stilgoe, Jack ; Thrasher, Adrian ; Wilson, James

The Lancet (British edition), 2018-03, Vol.391 (10123), p.883-910 [Periódico revisado por pares]

England: Elsevier Ltd

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Título:
Lancet Commission: Stem cells and regenerative medicine
Autor: Cossu, Giulio ; Birchall, Martin ; Brown, Tracey ; De Coppi, Paolo ; Culme-Seymour, Emily ; Gibbon, Sahra ; Hitchcock, Julian ; Mason, Chris ; Montgomery, Jonathan ; Morris, Steve ; Muntoni, Francesco ; Napier, David ; Owji, Nazanin ; Prasad, Aarathi ; Round, Jeff ; Saprai, Prince ; Stilgoe, Jack ; Thrasher, Adrian ; Wilson, James
Assuntos: Adult ; Animals ; Bioethics ; Biotechnology ; Bone Marrow Transplantation - legislation & jurisprudence ; Bone Marrow Transplantation - methods ; Burns - surgery ; Burns - therapy ; Clinical medicine ; Clinical Trials as Topic ; Cost-Benefit Analysis - statistics & numerical data ; Embryonic Stem Cells - transplantation ; Epidermis - transplantation ; Ethics ; Funding ; Gene therapy ; Genetic engineering ; Genetic Therapy - economics ; Genetic Therapy - methods ; Health Services Accessibility - standards ; Health Systems Agencies - economics ; Health Systems Agencies - legislation & jurisprudence ; Hematologic Diseases - surgery ; Hematologic Diseases - therapy ; Humans ; Induced Pluripotent Stem Cells - transplantation ; Medical research ; Medicine ; Models, Animal ; Patients ; Public good ; Regeneration (physiology) ; Regenerative medicine ; Regenerative Medicine - economics ; Regenerative Medicine - legislation & jurisprudence ; Regenerative Medicine - trends ; Stem Cell Research - ethics ; Stem cells ; Stem Cells - physiology ; Therapies, Investigational - ethics ; Tissue engineering ; Tissue Engineering - economics ; Tissue Engineering - legislation & jurisprudence ; Tissue Engineering - trends
É parte de: The Lancet (British edition), 2018-03, Vol.391 (10123), p.883-910
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
content type line 23
ObjectType-Review-1
Descrição: The only cross-cutting issue common to all emerging biotechnologies is indeed that they are emerging. [...]we have focused precisely on this process of emergence, and on the conditions that shape it. With the palpable sense of (probably disproportionate) public excitement and expectation around stem cell therapies, it is the scope, rather than the scale, of the health benefits they promise that makes them relevant. Because of this promise, a number of substantial challenges must be addressed if stem cell and regenerative medicine is to deliver sustainable, clinically significant, and equitable benefits. An urgent challenge could arise from the current combination of the political economy of hope invested in stem cell therapies,2-4 the relative lack of established therapies, and the persistence of a substantial cross-border market in untested and potentially ineffective therapies.5 The great risk of the current situation is highlighted by the case of Vannoni in Italy, in which the Stamina Foundation initially succeeded in obtaining direct authorisation from the Italian Government to administer an unproven therapy to patients, thus bypassing the country's regulatory authorities.6 The risk goes deeper than possible harm to individuals. Within a global context, issues of ethics and inequalities might apply differently to Europe and the USA than in countries with emerging economies, with doctrinal and ideological dimensions, culturally specific meaning in different global locales, and cross-cultural differences that have hitherto unseen moral and ethical complexities holding an equivalent relevance.7, 8 Key messages Existing research is hampered by reduced funding for the best quality basic research, frequent absence of strong preclinical evidence, poor trial design, and poor and inconsistent reporting, particularly of non-randomised trials Evidence of the cost-effectiveness of regenerative medicine is exceedingly sparse and more is needed; the rarity of many conditions for which regenerative medicine is indicated means that uncertainty surrounding the expected effectiveness and cost-effectiveness will be ongoing and substantial Understanding expectations of patients and the broader public is key to maintaining public trust in cell and gene therapies; the current gap between public expectations and the realities of translating regenerative technologies threatens the social licence of regenerative medicine to operate Cell and gene therapies require a strong governance framework oriented towards the public interest; given the uncertainty and contested nature of the current social contract for these therapies, it is a mistake to think that the answer is more science with less regulation Recommendations Preclinical work in animals should be done as rigorously as clinical experimentation; evaluation and reporting of trial results should be extremely detailed to allow appropriate moves to phase 2b and beyond Institutions should invest more to develop clinician scientists and reduce the burden of this double career, which would facilitate the transition from preclinical to clinical work; more academic good medical practice facilities should be created to make trials more affordable Research into how cell and gene therapies can become cost-effective and scalable should be a priority; the incorporation of wider societal benefits from new therapies within the appraisal framework should be considered in tandem with current work in this area more broadly An international register of cell and biological experimental interventions should be created, and sustainable funding secured for it, possibly within the European Medicines Agency and US Food and Drug Administration, but with a careful process of review to guarantee the scientific soundness of trials Policy should be developed by the International Committee of Medical Journal Editors so that trials reporting results of cell and biological therapies will not be published unless trials have been registered in the proposed international register The initial review for every experimental therapy should consider the relevant social and regulatory context Researchers and others involved in funding, publishing, and communicating stem cell research should integrate some responsibility for public dialogue into their research, engagement, and communication plans; such plans should include appropriate use of social media and internet forums Fortunately, there is now general agreement of a need to discuss and scrutinise technologies upstream-that is, when they are still at a relatively early stage, rather than waiting until they are ready to be deployed.9 As we discuss in this Commission's section on public engagement and trust, guidelines from the International Society of Stem Cell Research (ISSCR) and from the International Society of Cell Therapy (ISCT) now define the criteria for a correct and timely translation of stem cell research to clinics, and identify unproven therapies as a real danger for patients.10-12 In principle, such upstream engagement fosters open dialogue among scientists and different public audiences.
Editor: England: Elsevier Ltd
Idioma: Inglês

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Lancet Commission: Stem cells and regenerative medicine

England: Elsevier Ltd

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