Future Directions in Regenerative Medicine

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Publication Date: 2011-02-24

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This report covers the development of therapies to replace human cells or promote their regeneration: including cell therapies, tissue engineering, drugs, and medical devices. Each company profiled has at least one project in preclinical or Phase I study. Many also have later stage or launched products, which are covered briefly to illustrate the potential of the next generation of candidates.



The first regenerative cell therapies to generate significant market value (within the next five years) will be based on allogeneic adult cells, and will target tissues that are naturally sheltered from patients’ immune systems.

Autologous cells are not rejected by the patient’s immune system, so are potentially safer than allogeneic cells and more suitable for permanent tissue replacement. “High tech” therapies based on reprogrammed autologous cells (e.g. induced pluripotent stem cells) may still be 20 years from market.

Tissue engineering still faces technical hurdles, including vascularization of grafted tissue and safe breakdown of scaffold materials. Research and regulatory efforts must be coordinated internationally to develop a stronger “evidence base” for regenerative medicine that is accessible and acceptable to all stakeholders.


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