Appendix C

Statement of Task

The Forum on Regenerative Medicine will hold a public workshop to explore potential promising approaches to modulate the immune system and/or the regenerative medicine product for improving the clinical outcomes of tissue repair and regeneration in patients.

Workshop discussions may examine:

• lessons learned from other fields (e.g. organ or bone marrow transplantation) about the role of the host’s immune system in accepting a graft to inform whether manipulation of a graft can impact the acceptance or rejection of it;
• topics such as potential approaches for modulating critical immune system pathways and communication mechanisms between the immune system and damaged and/or diseased tissues;
• the application of these lessons learned to the development and use of regenerative medicine products, for example:
  • what immune factors and pathways play a role in regeneration;
  • biomarkers that may be useful for assessing a patient’s immune status or response to regenerative medicine therapies;
  • scaffolds, biomaterials, and other bioengineering tools that may modify immune responses; and
  • imaging technologies to leverage immune surveillance in patients and evaluation of the results of regenerative therapies.

A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize the workshop, select and invite speakers and discussants, and moderate the discussions. Proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.