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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American College of Toxicology Annual Meeting

November 14, 2022

Denver, Colorado, USA

Don’t miss the overview of CT-TRACS’ Advanced Sequencing project as well at a talk by the GTTC on the HESI Nitrosamine Subgroup at the upcoming American College of Toxicology Annual Meeting.

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CT-TRACS at Advanced Therapies 2022 Congress

May 25, 2022

London, United Kingdom

HESI's Cell Therapy – TRAcking, Circulation & Safety (CT-TRACS) Committee will present preliminary results of their pilot project “New approaches for identification of potential off-target mutations associated with CRISPR genome editing in cell therapies” at the Advanced Therapies 2022 Congress, London, UK, as ...

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Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee Regulatory Perspectives Webinar

September 28, 2021

Zoom webinar, co-organized by EATRIS and the HESI CT-TRACS Committee

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar on September 28, 2021 featuring three speakers who will share regulatory perspectives from both sides of the Atlantic. This activity is party of the CT-TRACS Committee's efforts to continue filling the knowledge gap about ...

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The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is hosting a virtual workshop focusing on the state of the science for a wide array of protein toxins classes, MOAs, structures, activity, and general biology. Additionally, the workshop will cover the bioinformatics analysis of protein toxins and how to leverage computational biology for protein toxins identification/characterization, with in silico approaches. 


The Protein Toxins Workshop will serve the dual purpose of learning from the experts in the field about the state of the science as well as assessing the translation of knowledge to practical applications, e.g., into weight-of-evidence approaches for the safety assessment of biotechnology products. The workshop aims to gain insight into how feasible/useful (or not) a protein toxin database could be in risk assessment/product development. This meeting will serve as an informational platform about HESI and will demonstrate the advances in protein toxins research, presented by international experts, and will help inform the development of novel approaches for the identification and classification of potential toxicity risk in novel proteins.


Details


    

  • Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
    • 

  • Time: 9:00 AM - 12:00 PM EST
    • 

  • Registration: Details coming soon
    • 


				PATC_resize
	
Workshop Program Outline (subject to change)


Wednesday, 21 October 2020


    

  • 9:00 AM - Opening Remarks (Dr. Laura Privalle, BASF Corporation)

      

    • From protein toxins to biotechnology products
      • 

    • Setting the stage; considerations for publication of meeting report
      • 

    

    • 

  • 9:30 AM - Brief Codex Discussion

      

    • Allergenicity assessment vs. toxins/toxicity assessment
      • 

    

    • 

  • 10:00 AM - Terrestrial Toxins
    • 

  • 11:30 AM - Marine Toxins
    • 



 


Thursday, 22 October 2020


    

  • 9:00 AM - Bacterial Toxins
    • 

  • 10:30 AM - Bioinformatics & Computational Biology in Protein Toxins Research
    • 



 


For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.


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Committee Publications

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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 ...

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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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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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