World Stem Cell Summit 2014 report part 3: policy, regulation, social and ethical issues
Part 3 from the conference scene of the World Stem Cell Summit (WSCS) 2014 held in San Antonio (3—5 December, San Antonio, Texas)
World Stem Cell Summit (WSCS) 2014 was held in San Antonio, Texas, USA from December 3 to 5. Among the many international conferences in the field of stem cells and regenerative medicine, WSCS is distinct in focusing its efforts to serve as the meeting point by multi-sector communities of research, clinics, industry, regulation, policy making and ethics. All are aiming at advancing stem cell innovation and new therapies, under the banner of “connect, collaborate and cure.” As same as past years, presenters and attendees included not only researchers but also clinicians, funding agencies, government officials, industries and patients. Thus, many sessions focused on the clinical translation from basic research. Another important agenda were industrial and social aspects, and problems to be solved before realization of practical and sustainable stem cell-based therapies.
Policy, regulation, social and ethical Issues
It is very important to construct and manage stem cell banking and registries. Andreas Kurtz (Charite Universitatsmedizin) talked about the importance of hESC registry with transparency, ethical provenance, scientific quality, global access and sufficient information. Mahendra Rao (NYSCF) talked about FDA regulation on clinical grade hPSCs and differentiated cell products, and also NIH strategy on Cell for Therapy. Zachary Resch (Mayo Clinic) talked about Mayo Clinic’s regenerative medicine blueprint which covers from project design to distribution of different kinds of stem cells. Tenneille Ludwig (WiCell) talked about the role of the International Stem Cell Banking Initiative (ISCBI) for the banking and distribution of hESC and hiPSC lines.
New Japanese regulatory framework for regenerative medicine & cell therapy has been effective since November 2014. Satoshi Yasuda (National Institute of Health Sciences) talked about new product category, Regenerative Medical Products (RMPs). The main concept is that the conditional/term-limited marketing authorization for RMPs will be granted to provide the products to patients after the safety confirmation and efficacy prediction by the clinical trial data. Takuya Yokokawa (Fujifilm Corporation & FIRM) presented industrial view of the Japanese situation. FIRM (The Forum for Innovative Regenerative Medicine) was established in 2011 with membership of over 100 companies. Cooperation with the government agencies resulted in an innovative regulatory framework for regenerative medicine.
A latest topic of pluripotent stem cells is the SCNT-ES cells, which are hPSCs produced by reprogramming through somatic cell nuclear transfer (SCNT) using oocytes. Dieter Egli (NYSCF) gave lectures in a plenary session and also in the session modulated by Mahendra Rao (NYSCF). Besides reprogramming biology, many social, ethical and policy issues are involved. Aaron Levine (Georgia Tech) gave a summary of ethical and political issues surrounding the SCNT. An important issue is distribution and research use of the derived SCNT-ES cell lines, because comparison of these cell lines with hESC and hiPSC lines by other laboratories can greatly advance understanding of pluripotency. However, ethics guidelines in many states and countries prohibit such scientific investigation. The moderator closed the session by saying that regulation should change by advancement of technology.
In the stem cell field, we have experienced poor reproducibility of published research results. Many cases may be due to instability of the cell line characteristics. It is indispensable, however, to obtain higher reproducibility and robustness for clinical application of stem cells. In a session of reproducibility and rigor in research, three speakers gave their thoughts and lessons to be learned. Graham Parker (Editor-in-Chief of Stem Cells and Development) gave an overview. Retraction of published papers has increased drastically from around 10 per thousand in 2000 to 50 in 2014. The most prominent example is retraction of 183 papers by single senior author. Recently increasing trends are activities of cloud-watching misconducts and rise of the post-publication peer review. Jeanne Loring (Scripps Research Institute) focused on misconducts in the stem cell field. She reviewed the famous case of fabricated SCNT-ES cell line derivation by Hwang Woo Suk in 2004-5, which was exposed by a postdoc whistle blower. Recently, we witnessed the STAP (Stimulus-Triggered Acquisition of Pluripotency) cell paper misconduct, which was quickly exposed by many volunteer researchers examining on line. Both have overlapping factors such as high profile journals, excess publicity by the host institution, scientific and national hero creation. Many more cases, however, are occurring in the stem cell fields, and we need more rigor in checking reproducibility and co-authorship responsibility. Ivan Oranski (Co-Founder of Retraction Watch) suggested problems of not enough clarification and definition in the biomedical research fields. In addition, large stakes of funding, social attention and impact, and increased competition in the stem cell and medical fields may facilitate such misconducts for publishing prominent papers in high profile journals.
Authors: Kouichi Hasegawa, Takashi Asada, Shintaro Sengoku and Norio Nakatsuji (Institute for Integrated Cell-Materials Sciences, Kyoto University, Kyoto, Japan)
Disclosure: This work was partially supported by a grant from the New Energy and Industrial Technology Development Organization. N. Nakatsuji is a founder and shareholder of a hESC/iPSC-related company, ReproCELL, Inc.
The full conference scene is scheduled to be published in Volume 10 Issue 4 of Regenerative Medicine.