Regenerative Medicine

 Issues

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Why do people oppose stem cells?

Issues that have been banned under Proposition 71 

Most of the attention to ethical issues in regenerative medicine has been consumed by debate about the use of human embryonic stem cells in research, specifically, the destruction of embryos in order to create cell lines, disputes over the role of federal funding for research with human embryonic stem cells, and concerns about the safety, scientific purity, and adequacy of consent for the research use of human embryonic stem cell lines. 29

People also take issue with the creation of chimeras. A chimera is an organism that has both human and animal cells or tissues. Often in stem cell research, human cells are inserted into animals (like mice or rats) and allowed to develop. This creates the opportunity for researchers to see what happens when stem cells are implanted. Many people, however, object to the creation of an organism that is "part human". 30

Legal Issues

Companies and researchers developing cell-based and tissue engineering therapies have formed a lobbying group to improve the federal policy environment surrounding their efforts.

"The legislation is designed to facilitate advances in regenerative medicine by increasing [and] coordinating federal funding efforts in research and moving towards a regulatory paradigm that enables approval of safe and effective regenerative medicine products," explained Michael Werner, a partner in the Washington, D.C., law offices of Holland & Knight and co-founder of ARM, in an interview.

He says the association is also engaging FDA, CMS and other agencies to push for clearer and more coordinated policies for regenerative therapies, including bioengineered tissues and organs, stem cell treatments and related technologies. 31

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