Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee

Mission Statement

To establish a platform where an international network of experts from multiple sectors (public and private sector research scientists, regulators, clinicians, health foundations, and technology developers) can collaborate sharing knowledge, experience, and resources in the rapidly evolving field of cell therapy.

Recent News

HESI CT-TRACS is proud to be a partner in NC3Rs 2022 CRACK-IT challenge “T-ALERT: Animal-free tumourigenicity assessment of CAR-T and other genetically modified T cells”. CRACK-IT challenges provides UK and EU-based academics and SMEs with the opportunity to apply to develop new 3Rs tools, technologies or approaches and engage with new partners. The T-ALERT Challenge aims to develop an in vitro assay that can reliably evaluate tumourigenicity of human-engineered T cell therapies with the potential to be applied to multiple immune cell types.

As a partner, HESI and the CT-TRACS committee will help to create productive relationship between the challenge awardees and organisations that have expertise, data, or other resources that could support successful Challenge dissemination of the resulting technology. The HESI CT-TRACS Tumorigenicity Working Group  will leverage its successful track record of multi-laboratory evaluation of relevant methods and assays in support of tumorigenicity evaluation of cell therapy products in support of the challenge winners.

NC3Rs 2022 CRACK-IT Challenge T-ALERT Challenge

Working Groups

  • Point of Administration-Biodistribution (PoA/BD) Working Group (Cell Tracking)

    This working group aims to identify current approaches, gaps, and needs in monitoring/evaluating the fate and activity of cells after their administration in vivo, to assess the safety of cell-based therapies.

  • Tumorigenicity Working Group

    This working group aims to address concerns regarding the potential for tumorigenicity of PSC-derived products by assessing and/or developing methodologies and approaches that could support tumorigenicity evaluation.

HESI Staff

Leadership Team

  • Tineke van den Hoorn, PhD

    Medicines Evaluation Board, The Netherlands

  • Mick Fellows, PhD

    AstraZeneca

Committee Events

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CT-TRACS at ISCT2023

June 1, 2023

Paris, France

Dr. Mick Fellows, co-chair of the CT-TRACS Committee was invited to speak about the developments of the committee project on advanced sequencing methods for detection of off-target edits in genome editing, a project that received support from HESI EIC via its “Foresight Proposal” award.

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Society of Toxicology Meeting 2023

March 19, 2023 – March 23, 2023

Nashville, TN, USA

A number of HESI committees will have presentations and posters at the Society of Toxicology Meeting in Nashville, TN.

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Committee Publications

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International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies

Regenerative Medicine, 2023

Takeshi Watanabe, Satoshi Yasuda, Connie L Chen, Louise Delsing, ...

HESI’s Cell Therapy-TRAcking, Circulation & Safety Technical Committee completed an international, multisite study to evaluate the sensitivity and reproducibility of the highly efficient culture (HEC) assay, an in vitro assay to detect residual undifferentiated human pluripotent stem cells (hPSCs) in cell therapy ...

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Options for Imaging Cellular Therapeutics In Vivo: A Multi-Stakeholder Perspective

Cytotherapy, 2021

Helfer BM, Ponomarev V, Patrick PS, Blower PJ, Feitel A, ...

Cell-based therapies have been making great advances toward clinical reality. Despite the increase in trial activity, few therapies have successfully navigated late-phase clinical trials and received market authorization. One possible explanation for this is that additional tools and technologies to enable their ...

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Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider

Cytotherapy, 2019

Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, ...

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Here, we critically review currently available ...

Read more

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