Regulatory developments for non-hematopoietic stem cell therapeutics: perspectives from the EU, the USA, Japan, China, India, Argentina and Brazil.

ROSEMANN, ACHIM; BORTZ, GABRIELA; VASEN, FEDERICO

A Roadmap to non-Hematopoietic Stem Cell-based Therapeutics: From the Bench to the Clinic

Elsevier

Año: 2018; p. 463 - 492

This chapter explores regulatory developments for non-hematopoietic stem cellstherapies in Japan, China, India, Argentina, Brazil, the USA and the European Union.The chapter illustrates that the research methods, ethical standards and approvalprocedures for the market use of non-hematopoietic stem cell interventions haveundergone an important process of global diversification. Part I introduces theregulatory conditions for non-hematopoietic clinical stem cell research andapplications in each of the above countries. Part II discusses these findings anddiscern three dynamics of regulatory diversification. Part III reflects on theadvantages and disadvantages of different regulatory approaches across countries.The forth and final Part examine some of the roadblocks that presently prevent theclinical translation of non-hematopoietic stem cell-based therapies.