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.

Partnerships

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

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Pluripotent Stem Cell Manufacturing Expert Panels 2019

June 30, 2019

Los Angeles, California, USA

After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS Tumorigenicity Workshop (Abbot et al., 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the ...

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				PSCM2019_Comm Image
	Date: June 30, 2019

Time: 13.00 - 18.00 PST

Location: Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC

First Floor, Seminar Room #101

1425 San Pablo Street, Los Angeles, CA 90033

 


After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS tumorigenicity workshop (conference report: Abbot et al. 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacturing and testing of pluripotent stem cell-based therapies.


 


The Pluripotent Stem Cells Manufacturing Meeting 2019 (PSCM2019) will be held on 30 June 2019 at the Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC (Los Angeles, California), following the International Society for Stem Cell Research (ISSCR) 2019 Annual Meeting. For more information, please contact Lucilia Mouriès (lmouries@hesiglobal.org).


 


This event is co-hosted by the following organizations:




 


Live-streaming information for the event and related materials will be available via GAiT’s website: http://www.gait.global/expert-panels-2019/


Start date in different time zones worldwide




See location on Google Maps

	
Agenda for the Expert Panels


 


13.00-13.25 Opening Panel: Review of takeaways from the June 2018 CIRM/IABS PSC Manufacturing, Standards, & Controls meeting; objectives and context for this year’s discussion.


    

  • Chair: Dr. Stephen Lin (CIRM)
    • 

  • Panel:
    • 



    

  • 

      

    • Assoc. Prof. Ngaire Elwood (ISCT)
      • 

    • Dr. Stephen Lin (CIRM)
      • 

    • Dr. Lucilia Mouriès (HESI CT-TRACS)
      • 

    • Dr. Yoji Sato (NIHS; HESI CT-TRACS)
      • 

    • Prof. Glyn Stacey (ISCBI)
      • 

    • Dr. Stephen Sullivan (GAiT)
      • 

    

    • 



 


13.30-13.55 Panel 2: Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast


    

  • Chair: Dr. Wen Bo Wang (Fate Tx)
    • 



 


14.00-14.25 Panel 3: International standardization of human pluripotent stem cell manufacturing – rationale and review of current status


    

  • Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)
    • 



 


14.30-14.55 Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development 


    

  • Co-Chair: Assoc. Prof. Ngaire Elwood ((Murdoch’s Children’s Research Institute/ISCT/FACT/ BMDI Cord Blood Bank)
    • 

  • Co-Chair: Dr. Amanda Mack (Fujifilm Cellular Dynamics International)
    • 



 


15.00-15.25 Panel 5: Outlining a road map to cell therapy comparability


    

  • Chair: Prof. Jo Mountford (SNBTS/University of Glasgow)
    • 



 


16.00-16.25 Panel 6: Towards standardized tumorigenicity testing – challenges and the way forward


    

  • Chair: Dr. Yoji Sato (NIHS; CT-TRACS Tumorigenicity WG)
    • 



 


16.30-16.55 Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture


    

  • Co-Chair: Dr. Elizabeth Schwarzbach (NYSCF)
    • 

  • Co-Chair: Dr. Mathilde Girard (YposKesi)
    • 



 


17.00-17.15 Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture


    

  • Co-Chair: Dr. Bill Shingleton, Assymtote
    • 

  • Co-Chair: Dr. Rajesh Ambasudhan (Allele Biotech)
    • 



 


17.20-17.35 Panel 9: Avoiding immunorejection and engraftment failure – challenges and the way forward


    

  • Chair: Dr. Stephen Sullivan (GAiT)
    • 



 


17.40-18.00 Closing Panel: Organizers summarizing and highlighting upcoming events


    

  • Co-Chair: Dr. Stephen Lin (CIRM)
    • 

  • Co-Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)
    • 



 


See more on the format and recommendations for participation here.


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				PSCM2019_Comm Image
	Date: June 30, 2019

Time: 13.00 - 18.00 PST

Location: Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC

First Floor, Seminar Room #101

1425 San Pablo Street, Los Angeles, CA 90033

 


After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS tumorigenicity workshop (conference report: Abbot et al. 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacturing and testing of pluripotent stem cell-based therapies.


 


The Pluripotent Stem Cells Manufacturing Meeting 2019 (PSCM2019) will be held on 30 June 2019 at the Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC (Los Angeles, California), following the International Society for Stem Cell Research (ISSCR) 2019 Annual Meeting. For more information, please contact Lucilia Mouriès (lmouries@hesiglobal.org).


 


This event is co-hosted by the following organizations:




 


Live-streaming information for the event and related materials will be available via GAiT’s website: http://www.gait.global/expert-panels-2019/


Start date in different time zones worldwide




See location on Google Maps

	
Agenda for the Expert Panels


 


13.00-13.25 Opening Panel: Review of takeaways from the June 2018 CIRM/IABS PSC Manufacturing, Standards, & Controls meeting; objectives and context for this year’s discussion.


    

  • Chair: Dr. Stephen Lin (CIRM)
    • 

  • Panel:
    • 



    

  • 

      

    • Assoc. Prof. Ngaire Elwood (ISCT)
      • 

    • Dr. Stephen Lin (CIRM)
      • 

    • Dr. Lucilia Mouriès (HESI CT-TRACS)
      • 

    • Dr. Yoji Sato (NIHS; HESI CT-TRACS)
      • 

    • Prof. Glyn Stacey (ISCBI)
      • 

    • Dr. Stephen Sullivan (GAiT)
      • 

    

    • 



 


13.30-13.55 Panel 2: Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast


    

  • Chair: Dr. Wen Bo Wang (Fate Tx)
    • 



 


14.00-14.25 Panel 3: International standardization of human pluripotent stem cell manufacturing – rationale and review of current status


    

  • Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)
    • 



 


14.30-14.55 Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development 


    

  • Co-Chair: Assoc. Prof. Ngaire Elwood ((Murdoch’s Children’s Research Institute/ISCT/FACT/ BMDI Cord Blood Bank)
    • 

  • Co-Chair: Dr. Amanda Mack (Fujifilm Cellular Dynamics International)
    • 



 


15.00-15.25 Panel 5: Outlining a road map to cell therapy comparability


    

  • Chair: Prof. Jo Mountford (SNBTS/University of Glasgow)
    • 



 


16.00-16.25 Panel 6: Towards standardized tumorigenicity testing – challenges and the way forward


    

  • Chair: Dr. Yoji Sato (NIHS; CT-TRACS Tumorigenicity WG)
    • 



 


16.30-16.55 Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture


    

  • Co-Chair: Dr. Elizabeth Schwarzbach (NYSCF)
    • 

  • Co-Chair: Dr. Mathilde Girard (YposKesi)
    • 



 


17.00-17.15 Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture


    

  • Co-Chair: Dr. Bill Shingleton, Assymtote
    • 

  • Co-Chair: Dr. Rajesh Ambasudhan (Allele Biotech)
    • 



 


17.20-17.35 Panel 9: Avoiding immunorejection and engraftment failure – challenges and the way forward


    

  • Chair: Dr. Stephen Sullivan (GAiT)
    • 



 


17.40-18.00 Closing Panel: Organizers summarizing and highlighting upcoming events


    

  • Co-Chair: Dr. Stephen Lin (CIRM)
    • 

  • Co-Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)
    • 



 


See more on the format and recommendations for participation here.


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Committee Publications

Filter

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

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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