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

CT-TRACS committee is an international network of experts from multiple sectors (public and private sector research scientists, regulators, cell therapy developers, clinicians, imaging experts, and enabling tool developers) who work collaboratively sharing knowledge, experience, and resources to secure the safety of cell-based therapies.

Mission Statement

To facilitate the translation of cell-based therapies to the clinic by driving the development of tools, methods and knowledge required to evaluate safety and fate of therapeutic cells.

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.

Stakeholder Survey

HESI’s Cell Therapy – TRAcking, Circulation, & Safety committee Biodistribution working group is launching an initiative 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. As a result, we are reaching out to the broader scientific community, in Advanced Therapies, Regenerative Medicine and/or Imaging fields, to gather your valuable feedback.

Please help us gather important stakeholder input in this innovative and critical area by completing this short survey by 31 May 2024. Completion time is estimated at 10 min.

The outcome will be published in the peer-review literature to benefit the broader community.

Survey Link

HESI Staff

Leadership Team

  • Tineke van den Hoorn, PhD

    Medicines Evaluation Board, The Netherlands

  • Mick Fellows, PhD

    AstraZeneca

Committee Events

Filter

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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Next Generation CAR & T-Cell Therapies Conference

June 22, 2021 – June 24, 2021

Virtual conference, hosted by Informa Connect

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee will be represented at the Next Generation CAR & T-Cell Therapies Conference on June 22, 2021 from 10:30am-10:50am PST in a presentation titled "Creating a Feedback Loop Between Clinical Trials and Translational Science for Product ...

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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. 


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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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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

Filter

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 ...

Read more

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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