The Regulation of Clinical Stem Cell Research and Applications: three dynamics of global regulatory diversification (part 2)

Written by RegMedNet

In the second part of this commentary, Achim Rosemann discusses the flexible enforcement of regulatory standards.

Read part one, an introduction to the regulatory landscape of clinical stem cell research and the emerging of a growing number of regulatory exceptions and exemptions.

Part three, thoughts on abandoning of the multiphase trial system and concluding remarks, is coming soon!

Achim Rosemann1

Centre for Education Studies, Faculty of Social Sciences, University of Warwick, Coventry, CV4 7AL.

Email: [email protected]

The flexible enforcement of regulatory standards

A second process of regulatory diversification is the flexible enforcement of regulatory rules in some countries, that enables the continued provision of experimental for-profit interventions with stem cells outside of the review and control structures of regulatory agencies. This has happened for various years in India and China, where governments responded only gradually to a flourishing grey-area market of stem cell therapies (Sleeboom-Faulkner and Patra 2011; Sleeboom-Faulkner et al. 2016; Sleeboom-Faulkner 2016).

Unapproved for-profit therapies continue to be tolerated in these countries also after the introduction of national regulatory frameworks, which formally prohibit stem cell interventions outside of formally approved clinical trials. In China, the 2015 Regulation for Clinical Stem Cell Research has explicitly stated that the clinical translation of stem cell-based approaches must occur through systematic clinical studies, which must follow from sound pre-clinical evidence (Rosemann and Sleeboom-Faulkner 2016). The core of this regulation is that stem cell trials can only be conducted in specifically authorized research hospitals and that for-profit applications of experimental stem cell interventions are legally prohibited (ibid.).

Also in India, the 2013 Guidelines for Stem Cell Research (and previously in 2007 the Guidelines for Stem Cell Research and Therapy) have formally prohibited the use of stem cells in human patients, except in the context clinical trials approved by India’s health authorities (Viswanathan et al. 2013; Indian Council of Medical Research 2013).

Despite these formal regulatory prohibitions, however, large private hospitals and medical corporations have continued to offer their services on the Internet in both countries. In China various private clinics and companies continue to advertise stem cell treatments on the world-wide-web, including on English language websites that aim to attract international patients. Also in India, numerous stem cell clinics have an online presence and advertize to stem cell-based interventions for a broader range of conditions.

However, the toleration of unapproved stem cell therapies has by no means been restricted to middle-income countries, but it could also be observed in the USA. In the USA, the FDA took for several years a surprisingly relaxed approach to clinics that have offered autologous stem cell interventions to patients, which have sprouted all over the country during the last 8-10 years.

According to research conducted in 2015, there are at present more than 350 US private clinics and businesses offering direct-to-consumer stem cell interventions to medical consumers, which have not been authorized by the US FDA. These interventions did not only include autologous stem cell treatments, but also interventions with autologous stem cells from multiple sources, and at least one clinic claimed to offer even human embryonic stem cell-based interventions (Turner and Knoepfler 2016).

With a growing number of right-to-try laws in the USA and recent regulatory changes introduced by the 21st Century Cures Act, and further changes announced by the current Trump government, this large number of clinics can be expected to expand rather than to be clamped down.

Read part one, an introduction to the regulatory landscape of clinical stem cell research and the emerging of a growing number of regulatory exceptions and exemptions.

Part three, thoughts on abandoning of the multiphase trial system and concluding remarks, is coming soon!


  • This article has benefited from research support provided by the ERC (283219) and the ESRC (ES/I018107/1).


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