Category: OoC

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The ISSCR Releases Global Standards to Enhance Rigor and Reproducibility of Stem Cell Research

The International Society for Stem Cell Research (ISSCR) released the ISSCR Standards for Human Stem Cell Use in Research, an international collaboration aimed at enhancing rigor in preclinical research and ultimately strengthening the pipeline of therapies for patients. Christine Mummery and colleagues were among the many dedicated expert scientists who established this document. These new guidelines will also provide invaluable aid to authors, journal editors, and reviewers in the stem cell field when considering publications.

“This nearly two-year initiative is groundbreaking for the global stem cell research community,” said Haifan Lin, ISSCR president. “The international standards will make a big difference in the quality of science that is performed and published worldwide.”

The ISSCR is the preeminent international stem cell research society with a reputation for scientific and ethical rigor and has produced field-shaping documents such as the Guidelines for Stem Cell Research and Clinical Translation. The current initiative, which establishes the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells, is led by an international taskforce of scientists chaired by Tenneille Ludwig, WiCell Research Institute, USA and Peter Andrews, University of Sheffield, UK. The ISSCR’s standards for basic and preclinical research draws from previous work to improve the reproducibility of research using pluripotent stem cells, such as that from the International Stem Cell Initiative (ISCI) and the International Stem Cell Banking Initiative (ISBCI), and address tissue stem cells and stem cell-derived model systems with the overall goal of improving reproducibility of experiments from lab to lab and from cell line to cell line.

“The ISSCR Standards represent a huge step forward in articulating Best Practice for use of stem cells in research,” said Tenneille Ludwig, co-chair of the taskforce that developed the recommendations. “When adopted, these basic principles will help drive rigor and reproducibility within the laboratory and improve both the quality and rate of science in our field.  It was an honor to work with such an experienced, dedicated, passionate group of true stem cell legends to establish this consensus document. The commitment to collaborative effort ultimately resulted in a strong document that will drive the field forward.”

One of the most impactful outcomes of the initiative is the development of the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist. The checklist is intended to help scientists, reviewers, and editors prepare and assess manuscripts for inclusion of critical details relevant to work with pluripotent stem cells (PSCs) and tissue stem cells (TSCs) with the goal of increasing the rigor and reproducibility of research through reporting.

“Stem Cell Reports views these new guidelines as an invaluable aid to authors, journal editors, and reviewers in the stem cell field,” said Martin Pera, Editor-in-Chief of Stem Cell Reports. “At our journal, we will be introducing the checklist for authors that accompanies the guidelines on a trial basis soon and soliciting their feedback along with that of reviewers and our Editorial Team. My colleagues and I feel this is a major step forward in ensuring rigor and reproducibility in all areas of stem cell research.”

Learn more about the evolution of the recommendations made in the ISSCR Standards by reviewing the society’s open access Standards webinars on ISSCR.digital and attending the ISSCR 2023 Annual Meeting in Boston, USA 14-17 June 2023. Visit ISSCR.org/standards-document for the full text and to download the PDF of the ISSCR Standards for Human Stem Cell Use in Research and the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist.

The ISSCR Standards initiative is supported through contributions by Burroughs Wellcome Fund (BWF), Doris Duke Charitable Foundation (DDCF), and the Simons Foundation Autism Research Initiative (SFARI). Learn more about their support.

About the International Society for Stem Cell Research (www.isscr.org)
With more than 4,600 members from 80 countries worldwide, the International Society for Stem Cell Research is the preeminent global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. Additional information about stem cell science is available at A Closer Look at Stem Cells, an initiative of the society to inform the public about stem cell research and its potential to improve human health.

 About Burroughs Wellcome Fund

The Burroughs Wellcome Fund (BWF) serves and strengthens society by nurturing a diverse group of leaders in biomedical sciences to improve human health through education and powering discovery in frontiers of greatest need. BWF was founded in 1955 as the corporate foundation of the pharmaceutical firm Burroughs Wellcome Co. In 1993, a generous gift from the Wellcome Trust in the United Kingdom, enabled BWF to become fully independent from the company, which was acquired by Glaxo in 1995. 

 About Doris Duke Charitable Foundation

The mission of the Doris Duke Charitable Foundation is to improve the quality of people’s lives through grants supporting the performing arts, environmental conservation, child well-being and medical research, and through preservation of the cultural and environmental legacy of Doris Duke’s properties. The foundation’s Medical Research Program supports clinical research that advances the translation of biomedical discoveries into new preventions, diagnoses and treatments for human diseases. To learn more about the program, visit www.ddcf.org.

Source: ISSCR
Download the new standards here

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Workshop OoC in Paris: France federates its OoC community

On February 23rd  and 24st, 2022, the plenary meeting for the structuring of the OoC sector in France was held in Paris, organized by BioValley France (BVF), Institut Curie/IPGG and the CEA-IRIG (Interdisciplinary Research Institute of Grenoble). This event is a continuation of the digital directory of French experts in OoC set up by BVF (https://www.biovalley-france.com/fr/territoire/france/organe-sur-puce/ ).

These 2 days gathered about 95 people, 65 of which were in person, which was a great opportunity for human interaction and everyone enjoyed it! Peter Loskill, the chair of EUROoCS introduced this 2-days Workshop with a keynote to give an overview of OoC and associated applications. Berend van Meer illustrated the Dutch success story of national infrastructure structuring by presenting hDMT (https://www.hdmt.technology) and NOCI (https://noci-organ-on-chip.nl/). French researchers, clinicians, pharmaceutical and biotech companies, as well as representatives of the Ministry and standardization committees, were able to discuss in round tables the means to be implemented in this new field in France and the positioning of OoCs in the value chain from research to clinical and industrial applications.

French OoC Workshop Organizers : Jean-Dominique Guitton et Marie-Charlotte Lechner (BioValley France) / N-Picollet Dhahan (CEA-IRIG) / Stéphanie Descroix (Institut Curie/IPGG)

This French national OoC sector, in synergy with EUROoCS, will reinforce the visibility and competitiveness of France and the EU in the deployment and adoption of OoC technologies for tomorrow’s medicine. The annual conference in July 2022 EUROoCS in Grenoble (France) (https://euroocs.eu/annual-meeting/) will be the opportunity to highlight this national community in full structuring while drawing up a state of the art of the recent advances of the field.

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Contribute to the Tumor Lymph Node-on-Chip End Users Questionnaire!

‘Tumor and Lymph Node-on-Chip for cancer studies’ (Tumor-LN-oC) is a Horizon 2020 EU project coordinated by the Institute of Communication and Computer Systems (ICCS) of the National Technical University of Athens and led by Professor Ioanna Zergioti who is the Principal Investigator. The consortium comprises 11 partners from the Industry and the Academia from 9 different EU countries.

Tumor-LN-oC aims to offer a comprehensive solution for a robust, automated tumor-lymph node-on-chip platform that will connect primary surgically removed human tumors and LN tissue from the same cancer patient. This will allow studying the interaction of primary tumors with lymph nodes, identifying their chemical signature, and offering personalized treatment relying on molecular characterization of lymph node metastasizing cells.
During the course of the project, there will be interaction both with the Regulatory Bodies and the stakeholders in order to understand the end-user requirements and to comply with the existing regulatory/legislative framework. For this reason, a short questionnaire has been prepared on end-users’ requirements and needs for an Organ-on-Chip (OoC) platform for metastasis diagnosis and drug testing.

The Tumor-LN-oC platform is targeting the monitoring of complex processes such as tissue crosstalk and metastasis and will serve as a platform for parallel preclinical testing of drugs for individual patients aiming at Precision Medicine approaches. The survey includes questions related to the operation, the analysis time, the cost and other information that in the end will co-shape the platform that will be developed during the course of the project.

If you or anyone you know would be interested in contributing, please fill out the form and don’t hesitate to get in touch with the project coordinator (https://tumor-ln-oc.eu). Thank you for your participation!

Prof Ioanna Zergioti, Project Coordinator

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Open technology platforms for emerging medical domains

Last November the Health.E lighthouse released two white papers on open technology platforms for emerging medical domains with Organ-on-Chip of course being one of them.

In the first whitepaper emerging medical domains are identified. In the latest whitepaper the specific problems and challenges related to open platforms for medical  devices are discussed.

Open technology platforms that can be used for multiple applications by multiple end-users have resulted in an enormous pace of innovation in the electronic industry. Unfortunately, the medical device industry is still very much relying on non-scalable point solutions.

The lighthouses are an instrument initiated by the European ECSEL/KDT funding program

to streamline and focus European initiatives / projects in certain key areas, and one of them is Health.

It is the mission of the Health.E lighthouse to accelerate innovation in medical devices by promoting the development and adoption of open technology platforms in the medical domain.

Next to the published whitepapers, the lighthouse is organizing a public symposium the 8th/9th March 2022 where industry, SMEs, RTOs, and policy makers will share their views and experiences in relation to the development and deployment of open technology platforms for medical devices. If you are interested in this topic or perhaps want to show your open technology platform in a booth, you are welcome to participate and join us! Participation is free of charge but does require registration.

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Emulate Liver-Chip able to correctly identify 87% of drugs that caused drug-induced liver injury to patients

In a recent study now available on BioRxiv, researchers assessed the performance of 780 human Liver-Chips across a blinded set of 27 known hepatotoxic and non-toxic drugs. In line with the IQ MPS guidelines, the tested drugs included seven matched pairs that demonstrate the chip’s ability to distinguish toxic drugs from their less-toxic structural analogs. Furthermore, the study demonstrated that the Emulate Liver-Chip was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in patients despite passing through animal testing. At the same time, the Liver-Chip did not falsely flag any drugs as toxic, supporting its use in toxicology screening workflows. In comparison, published data for 3D hepatic spheroids shows a sensitivity rate of 42% and a specificity rate of 67% for the same drug set.

The study also included an economic evaluation indicating routine use of the Emulate Liver-Chip to identify liver toxicity risk in small-molecule drug development could generate approximately $3 billion per year by driving an increase in research and development productivity.

Source: Emulate

https://doi.org/10.1101/2021.12.14.472674

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CEN-CENELEC Organ-on-Chip Focus Group Creation

In April, the online workshop ‘Organ on Chip: Towards Standardization‘ took place as the 2021 edition of Putting Science into Standards (PSIS) in collaboration with the Joint Research Centre of the European Commission.

The PSIS workshop gathered more than 200 participants from academia, industry, policy makers, regulatory experts, and standardizers. You can find out more about the workshop and the different themes and issues that were discussed over its two-day run in this event report published by the JRC.

In June, it was decided by CEN and CENELEC Technical Board that a CEN-CENELEC Focus Group on Organ on Chip (FG OoC) would be established. The secretariat of FG OoC is held by NEN, the Royal Netherlands Standardization Institute. The Focus Group shall ensure interaction between all relevant European stakeholders interested in potential standardization in the field of OoC, map ongoing activities, define priority needs and opportunities and recommend further action to ensure that standards support the deployment of OoC in industry and help to ensure its regulatory acceptance.

The primary objectives of this Focus Group will be:

– developing an overview for the stakeholder community on suitable standards already publicly available or in preparation
– developing a roadmap for potential standardization issues relevant for OoC
– identifying and considering technical bodies addressing areas related to OoC technologies, such as ISO/TC 276 Biotechnology, ISO/TC 215 Health Informatics, CEN/TC 140 In vitro diagnostic medical devices, CEN/TC 251 Health Informatics;
– advising CEN and CENELEC Technical Boards on strategic issues concerning standardization within the Group’s overall remit and, where no suitable standard exists, the FG OoC should recommend best ways to provide them;
– identifying and considering any relevant specific issues linked to European legislation; liaising with innovation/research projects impacting the field of OoC;
– establishing an active dialogue between stakeholders and liaising with the European Organ-on-Chip Society (EUROoCS) to identify potential synergies.

The Focus Group will be holding its kick-off meeting virtually on 2 March 2022.from 1.30-4.30 pm (Amsterdam/Europe time).

Researchers and organizations active in Organ-on-Chip can express their interest in contributing to this Focus Group by contacting their National Standardization Bodies (NSBs-CEN) or National Committees (NCs-CENELEC), who will organise the contributions at national level to the Focus Group.

Contact: Livia MIAN lmian@cencenelec.eu

Source: https://www.cencenelec.eu/news-and-events/news/2021/briefnews/2021-12-13-cen-cenelec-organ-on-chip-focus-group-creation/

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The Intersection of Stem Cells and Engineering

Podcast with Christine Mummery and Peter Loskill

Following the publication of the Special issue on Organs-on-Chip in Stem Cell Reports, the guest editors Christine Mummery and Peter Loskill were invited by Martin Pera (Editor-in-Chief of Stem Cell Reports) to join the podcast to talk about the intersection of stem cells, microphysiological systems and Organs-on-Chip technology in understanding disease, screening drugs and personalized medicine.

 

Guests
Christine Mummery, PhD, Professor of Developmental Biology at Leiden University Medical Center heading the iPSC & Organ-on-Chip Hotel at the LUMC. She is also chair of hDMT, the Dutch Organ-on-Chip Consortium), the recent past chair of EUROoCS and the recent past president of the ISSCR.

Peter Loskill, PhD W3-Professor for Organ-on-Chip Research at the Eberhard Karls University Tübingen and the Natural and Medical Sciences Institute as well as the recent new chair of the European-Organ-on-Chip-Society (EUROoCS).

Host
Martin Pera, PhD, Editor-in-Chief, Stem Cell Reports and The Jackson Laboratory

Supporting Documents
Special Issue: Organs-on-Chip

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Tumor-LN-oC project has kicked-off

On May 7th, 2021 Tumor-LN-oC project (Tumor and Lymph Node on Chip for cancer studies) was officially kicked-off via online conferencing service where all partners from 11 organizations participated. The project is coordinated by Institute of Communication and Computer Systems from Greece, with the participation of Eindhoven University of Technology (Netherlands), Biomedical Research Foundation Academy Of Athens (Greece), Åbo Akademi (Finland), Alpes Lasers (Switzerland)), Rayfos Ltd (UK), Vienna University of Technology (Austria), Elvesys (France), PhosPrint P.C. (Greece), Asphalion SL (Spain) and Amires (Czech Republic).

Tumor-LN-oC aims to offer a comprehensive solution for a robust, automated tumor-lymph node-on-chip platform that will connect primary surgically removed human tumors and LN tissue from the same cancer patient. This will allow to study the interaction of primary tumors with lymph nodes, identify their chemical signature, and offer personalized treatment relying on molecular characterization of lymph node metastasizing cells.

Read the press release. For more information about the project visit the Tumor-LN-oC website.

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Recordings and presentations PSIS workshop on Organ-on-Chip now available

If you were not able to join the workshop Putting Science into Standards (PSIS) on standardization of Organ-on-Chip, please have a look at the presentations and discussions on the CEN-CENELEC website.

On 28-29 April 2021 the Putting Science into Standards (PSIS) workshop on Organ-on-Chip was held online. This workshop was organized by CEN-CENELEC and JRC in collaboration with experts of the Advisory board, including members of hDMT and EUROoCS. Many stakeholders from the Organ-on-Chip field, including developers, regulators and end users from industry were guiding or actively contributing to the online discussions in the different parallel sessions . At the end of the workshop the conclusions and perspectives for the way forward were summarized. The PSIS workshop was a very good kick-off for the standardization process of Organ-on-Chip.

On the event’s webpage post-event material including part of the recordings and the speaker’s presentations are published.

The report of the workshop is in preparation and the outcome will be used as starting point for the development of the Organ-on-Chip standardization roadmap.

 

 

 

 

 

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2021 edition of the ‘Putting Science into Standards’ (PSIS) workshop open for registration

Since 2013, the Joint Research Centre of the European Commission (JRC) and the European Standardization Organizations CEN and CENELEC have carried out an annual joint ‘foresight on standardization’ action under the Putting Science into Standards (PSIS) initiative. The PSIS initiative aims to facilitate the identification of emerging science and technology areas that could benefit from standardization activities to enable innovation and promote industrial competitiveness.

The 2021 PSIS edition will be focusing on Organ-on-Chip (OoC). This event aims to facilitate the exchange of views on the future development of this technology, its application areas and stakeholder needs in order to identify how European standardization can support its safe, widescale deployment, and by doing so also:

• facilitate their implementation in the current and future regulatory framework;
• support with reliable methods that are even more critical for use of OoC in emergency situations, when drug/vaccine development and testing procedures are necessary, as in the current COVID-19 drug rush;
• strengthen Europe’s position as leader in the promotion of more ethical use of animals in testing;
• help European OoC start-ups to increase their reliability and their market share.

For whom: Researchers, Innovators, Industry, Standardisers, Policy makers.

Registration: save your seat and register through the event website.

Resources: Download the event programme and brochure.

Hashtag: #Standards4OoC

Organisers:
The European Commission – Joint Research Centre (JRC)
Contact: Andreas JENET, Project Officer, Scientific Development Unit
The European Standardization Organizations: CEN and CENELEC
Contact: Samira NIK, Project Manager – Innovation; Livia MIAN, Project Manager – Innovation