Session Details

Workshop 4 - Optimizing Clinical Trials in Cellular Therapy
Saturday, September 14, 2019 10:45 AM - 12:15 PM
Plenary Hall
Cellular therapy has moved from being a fascinating early phase research area into a real-life clinical application that is now playing an important role in various clinical settings. This changing reality has brought to light a number of issues that are not so simple to solve. Expansion of single center clinical trial to multiple sites is associated with issues in regard to clinical design, cell collection, manufacturing and shipping, as well as logistical problems. Data must also be obtained, compiled and analyzed efficiently. The implication of pharmaceutical industry also requires significant adjustments. This session will discuss the various problems associated with this new paradigm and provide answers to overcome these obstacles.

Chair: Denis-Claude Roy, MD,FRCPC, Hopital Maisonneuve-Rosemont, Canada


Mesenchymal Stromal Cells for Sepsis: The Potential and the Challenges
Lauralyn McIntyre, MD, FRCPC, MSc, Ottawa Hospital Research Institute, Canada
Learning objectives:
•      Discuss biological rationale and evidence for MSCs in sepsis
•      Discuss challenges related to studying MSCs in sepsis clinical trials
•      Discuss MSC sepsis trials coming down the pipeline

Balancing Flexibility with Standardization to Bring Cell Therapy Trials to Fruition
Sarah Nikiforow, MD, PhD, Dana-Farber Cancer Institute, USA
Learning Objectives:
•      Identifying challenges to creating an academic ecosystem to safely and efficiently deliver multiple types of cell therapy in varied clinical settings
•      Define resource constraints and ripple effects throughout the institution (apheresis, cell processing, research and quality infrastructure, and clinical delivery sites
•      Quantify areas and extent of institutional investment to launch and delivery of novel cell therapies

Role of outcomes registries in cellular therapy
Steven Devine, MD, National Marrow Donor Program/CIBMTR, USA
Learning objectives:
•      To define the current role of outcomes registries in cellular therapy
•      To understand how an outcomes registry can facilitate the design of clinical trials in cellular therapy
•      To discuss the future role of registries in contributing to our understanding of cellular therapy outcomes, including late effects