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.

Call for Participants (March 2021): International Collaborative Study for the Identification of Off-Target Mutations Associated with Genome Editing

The CT-TRACS Committee is seeking additional partners (academic/research institutions, government agencies, non-profit institutions, private sector companies, or CROs) for an international collaborative project focused on advancing the application of sequencing technologies for identification and evaluation of off-target mutations that may be associated with genome editing via CRISPR Cas9. This initiative aims to advance the implementation of novel cell and gene therapies by improving the science underlying their safety evaluation. For full details on study objectives, rationale, roles for project partners, and instructions on how to express interest, please read the call for participants description document here.

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

  • Bill Shingleton, PhD

    Cytiva

Committee Events

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Workshop Agenda

[Download File]

Dr. Carla Herberts, Medicines Evaluation Board, Netherlands

Regulatory Perspective (I)

[Download Presentation]

Dr. James McBlane, MHRA, UK

Regulatory Perspective (II)

[Download Presentation]

Dr. Keiji Yamamoto, Takeda/FIRM, Japan

Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods

[Download Presentation]

Dr. Yoji Sato, NIHS, Japan

In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products

[Download Presentation]

Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

[Download Presentation]

Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

[Download Presentation]

Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

[Download Presentation]

Professor Phil Blower, King's College London, UK

Academic/Translational Perspective

[Download Presentation]

HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.

Topics and Learning Objectives:

1. Future needs in patient safety of cell-based therapies. Identify challenges and opportunities to enhance the accuracy and efficiency of safety assessment of cell therapy products. Perspectives from a broad range of stakeholders from design to implementation settings.

2. Evolving safety tools and applied safety techniques. Learn about in vivo cell tracking approaches and their role in supporting clinical translation, as well as methods for evaluating the potential tumorigenicity risk of cell-based therapeutic products.

3. Role of collaboration in cell therapy development and use. Explore international opportunities to bridge stakeholders and improve our ability to develop and implement effective standards.

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Workshop Agenda

[Download File]

Dr. Carla Herberts, Medicines Evaluation Board, Netherlands

Regulatory Perspective (I)

[Download Presentation]

Dr. James McBlane, MHRA, UK

Regulatory Perspective (II)

[Download Presentation]

Dr. Keiji Yamamoto, Takeda/FIRM, Japan

Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods

[Download Presentation]

Dr. Yoji Sato, NIHS, Japan

In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products

[Download Presentation]

Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

[Download Presentation]

Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

[Download Presentation]

Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

[Download Presentation]

Professor Phil Blower, King's College London, UK

Academic/Translational Perspective

[Download Presentation]

HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.

Topics and Learning Objectives:

1. Future needs in patient safety of cell-based therapies. Identify challenges and opportunities to enhance the accuracy and efficiency of safety assessment of cell therapy products. Perspectives from a broad range of stakeholders from design to implementation settings.

2. Evolving safety tools and applied safety techniques. Learn about in vivo cell tracking approaches and their role in supporting clinical translation, as well as methods for evaluating the potential tumorigenicity risk of cell-based therapeutic products.

3. Role of collaboration in cell therapy development and use. Explore international opportunities to bridge stakeholders and improve our ability to develop and implement effective standards.

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Committee Publications

Filter

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

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 ...

Read more

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

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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