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TMM 2017 - Breaking the mold: flourishing multicenter trials in Canada

(Contents are available in English only/Contenu disponible en anglais uniquement) 


Some of the challenges and opportunities of multicenter clinical trials were addressed by the panel of experts: preclinical trial design, manufacturing and shipping logistics, ethics, regulatory and costs.

November 7, 2017: CellCAN hosted a workshop at the Till&McCulloch Meetings in Mont-Tremblant. ‘’Breaking the mold: flourishing multicenter trials in Canada’’. It was a full house and attendees were able to learn from an empirical perspective the key factors for success in running multicenter clinical trials in Canada.

Dr. David Courtman (Ontario Hospital Research Institute), Dr. Imran Ahmad (CIUSS-de-l’est-de-l’Île-de-Montréal), Vasiliki Rahimzadeh, PhD(c) (McGill University) and Dr. Nadine Kolas, Senior Policy Analyst (Health Canada) came together in a panel moderated by Craig Hasilo, Chief Scientific Officer of CellCAN.

Missed it? The presentations & summaries are exclusively available here!

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Manufacturing Cell Therapy Products for Multicentre Clinical Trials: the OHRI experience

A presentation by Dr. David Courtman, Ottawa Hospital Research Institute

Mesenchymal Stem Cell Therapy for Canadians with Multiple Sclerosis (MeSCaMS) Trial is the Canadian portion of an International Multicentre trial: Mesenchymal Stem Cells for Multiple Sclerosis (MESEMS). The MesCaMs is currently being run in Ottawa and in Winnipeg. The International trial is currently being run in Australia, Canada, Denmark, France, Italy, United Kingdom, Spain, and Sweden.

In this presentation, Dr. Courtman:

  • Explained the unique characteristics of the MESEMS trial, as each country is getting its own funding and has to get its own regulatory approval.
  • Discussed cell product consistency/quality across sites as it is a possible liability in these trials.
  • Explained that although MESCAMs is a multicentre trial, it was reviewed as a stand-alone trial by HPB, with the international trial well under way (60 to 70 patients out of projected 170).
  • Shared his vision of how the involvement in the International trial was taken into consideration in Canada.

    Full presentation available exclusively here.

    The CARE Trial, Experience with a Canadian Multicentre Cell Therapy Trial

    A presentation by Dr. Imran Ahmad, CIUSSS-de-l’est-de-l’Île-de-Montréal

    The CARE trial: a Canadian National Transplant Research Program led clinical trial. This collaborative multicentre Canadian trial was performed at 6 clinical and 3 manufacturing sites. It was designed to test biological activity and clinical efficacy, bringing together expertise in cell production, immune monitoring and clinical practice.

    In this presentation, Dr. Ahmad: 

    • Reviewed the benefits and limitations of centralized versus decentralized manufacturing and how the CARE Trial made use of both for their multicentre approach.
    • Outlined the proficiency testing required for validation at each site.
    • Discussed cold chain transport validation.
    • Highlighted lessons learned for such an endeavour and considerations for future trials.

    Highlights from the multicentre CARE trial:

    • Dr. Ahmad outlined the design and implementation of the Continuous Alloreactive cell depletion and Regulatory cell Expansion trial for the treatment of graft versus host disease.
    • From a manufacturing perspective, one batch of collected cells are expanded to produce several batches for reinfusion.
    • A phototherapy was used to selectively deplete the alloreactive T-cells, and to facilitate an expansion of regulatory T-cells.
    • This autologous therapy was implemented through leukapheresis, manipulation and reinfusion after allogeneic transplant.

    Full presentation available exclusively here.

    Multisite Ethics Review and Clinical Trials in Canada

    A presentation by Vasiliki Rahimzadeh, PhD(c), McGill University?

    Stakeholders have been asking for ways to reduce the procedural inefficiencies, redundancies and delays in the Review of Ethics process when working on collaborative multicentre research. A single Research Ethics Board (REB) appears to be a potential solution to answer the needs of contemporary realities and practices of collaborative, data-intensive research typified by stem cell research and genomics.

    In this presentation, Mrs. Rahimzadeh:

    • Explained that ethics review approval processes for collaborative studies and recent policy forms across Canada apply to clinical trials involving innovative therapies and stem cells, but are not unique to them.
    • Discussed some of the provincial approaches to reducing the redundancies and inefficiencies that have become synonymous with the extant system of review, while facilitating collaborative multisite research typified by the stem cell and genomics research communities.
    • Suggested that multisite research within the respective provinces will purportedly improve with these reforms, but inter-provincial and international collaborations remain unchanged in terms of approval processes.
    • Explored what the Global Alliance is doing to address the latter.

    Full presentation available exclusively here.

    Considerations from the HC Perspective for Multicentre Clinical Trials

    A presentation by Dr. Nadine Kolas, Health Canada

    In this presentation, Dr. Kolas discussed considerations for Multicenter Trials from a regulatory perspective. The Challenges & Regulatory Concerns for Cell Therapy were identified and how these challenges may be amplified by hosting the trials and/or manufacturing at multiple sites.

    In this presentation, Dr. Kolas:

    • Explained how the HC Guidance Document for Preparation of a CTA should be used and interpreted.
    • Outlined important and relevant regulatory and international harmonization guidelines.
    • Outlined expectations from pre-clinical studies to ensure adequate risk-benefit balance and its influence on the choice of animal models used.
    • Described how both the materials used and the final product should be well characterized from a chemistry and manufacturing point of view.  

    Full presentation available exclusively here.

     

     

    • 13/12/2017

     

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