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Session Details

(CTSC) Mesenchymal Stromal Cells: Are They Ready for Prime Time?

Intended Audience: Physicians, Managers/Supervisors, Scientists, Technologists

Objectives:

  • Describe the characteristics and heterogeneity of MSCs.
  • Assess the status of current clinical trials of MSCs for the treatment of several diseases including ischemia, lung disease and neurodegenerative disorders.
  • Explore various manufacturing models and considerations for MSC product potency and assay development.

Event Description: Mesenchymal Stromal Cells (MSCs) are the current craze in cell therapy.  They are being tested in all kinds of indications.  Will they become part of standard of care? Ask four people about them and you will get four different answers. This interactive workshop aims to address these and other complex questions about their characterization, functionality and manufacturing considerations. World renowned researchers and clinicians will share the latest results in clinical trials of MSCs for conditions such as ischemia, lung disease and neurodegenerative disorders. Regulatory experts will discuss their perspective and leading industry experts will discuss strategies for scale up manufacturing, and commercialization.

Event Level: Intermediate to Advanced

 

Mesenchymal Stromal Cells: Are They Ready for Prime Time?

Workshop Schedule

7:30 am

Breakfast

8:00 am

Welcome Remarks

Mesenchymal Stromal Cells: Characterization and Clinical Applications

8:15 am

Characterization of MSCs: Tissue Sources, Heterogeneity, and Function

9:00 am

Adherent Stem Cell Therapy for Ischemic Stroke: Phase 2 Study Outcomes

9:30 am

MSCs for Graft vs. Host Disease Prophylaxis and Treatment

10:00 am

Next Generation MSC Products: Genetic Engineering and Combination Products for Tissue Engineering

10:30 am

Refreshment Break

Mesenchymal Stromal Cells: cGMP Manufacturing for Clinical Trials

10:50 am

MSCs for Multicenter Academia Trials

11:30 am

Optimizing MSCs for Emergent Use in Trauma

12:00 pm

Process Automation in MSC Manufacturing

12:30 pm

Lunch and Exhibits Open

1:45 pm

The Role of Blood Centers in Scaled Up Manufacturing of MSCs

2:15 pm

Stem Cell BioManufacturing and Sustainability

2:45 pm

Refreshment Break

New Frontiers and New Challenges: The Regulatory Landscape of MSCs

3:00 pm

FDA: CBER’s MSC Consortium – Regulatory Science for Improved Characterization of Cell Based Products

3:30 pm

Characterization of MSCs: Potency Assay Development

Forging a Path Ahead: Panel Discussion on Assays, Potency and Release Testing

4:00 pm

Overview of Current Landscape of MSC Assays and Potency

4:15 pm

Panel Discussion

5:00 pm

Closing Remarks and Adjourn to Networking Reception

5:30 pm

Networking Reception for Cellular Therapy