Cell and Gene Therapy - TRAcking, Circulation, & Safety (CGT-TRACS) Committee

SECURING THE SAFETY OF CELL & GENE THERAPIES TO REALIZE THEIR POTENTIAL

CGT-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 and gene therapies.

Mission Statement

To facilitate the translation of cell and gene therapies to the clinic by driving the development of tools, methods and knowledge required to evaluate their safety and fate.

Working Groups

  • Gene Therapies

    The CGT-TRACS Committee is excited to announce an expansion of its focus to include gene therapies as part of its ongoing commitment to advancing safety science in emerging advanced therapies. This addition reflects the growing importance of understanding and addressing safety concerns specific to these cutting-edge gene delivery systems, which are being increasingly utilized in clinical applications. By leveraging our existing expertise and global network, we aim to foster the development of best practices, innovative tools, and collaborative projects to support the safe translation of gene therapies to the clinic.

    A group of experts was convened in 2024 (from within existing participating organizations, as well as potential new future partners with a focus on gene therapy development) to identify key needs and gaps. Two new project proposals were developed and endorsed by the committee in 2024 and have been launched in Q1 of 2025:

    1. Methods for Integration Site Analysis and Data Interpretation
    2. Assessing Risk of Germline Transmission in AAV Gene Therapy Products (in collaboration with HESI DART committee)

    The committee is welcoming new partners with expertise in gene therapies development and their nonclinical safety assessment, with interest in advancing the field of safety science. Through our collaborative, pre-competitive forum, we aim to build a robust network of contributors. Reach out to committee managers Lucilia Mouriès and Connie Chen to express your interest and learn more.

  • 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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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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Center for Patient and Consumer Safety

The Cell and Gene Therapy – TRAcking, Circulation, & Safety (CGT-TRACS) Committee is part of the Center for Patient and Consumer Safety. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Patient and Consumer Safety:

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403

740 15th Street NW, Suite 600
Washington, DC 20005

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