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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Committee Publications

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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 ...

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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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