Background: Apart from haematopoietic stem cell transplantation for haematological disorders many stem cell-based therapies are experimental. However, with only 12 years between human embryonic stem cell isolation and the first clinical trial, development of stem cell products for regenerative medicine has been rapid and numerous clinical trials have begun to investigate their therapeutic potential.
Source of data: This review summarizes key clinical trial data, current and future perspectives on stem cell-based products undergoing clinical trials, based on literature search and author research.
Areas of agreement: It is widely recognized that the ability to stimulate stem cell differentiation into specialized cells for use as cellular therapies will revolutionize health care and offer major hope for numerous diseases for which there are limited or no therapeutic options.
Areas of controversy: Stem cell-based products are unique and cover a large range of disorders to be treated; therefore, there is significant potential for variation in cell source, type, processing manipulation, the bioprocessing approach and scalability, the cost and purity of manufacture, final product quality and mode of action. As such there are gaps in regulatory and manufacturing frameworks and technologies, only a small number of products are currently within late phase clinical trials and few products have achieved commercialization.
Growing points: Recent developments are encouraging acceleration through the difficulties encountered en route to clinical trials and commercialization of stem cell therapies.
Areas timely for developing research: The field is growing year on year with the first clinical trial using induced pluripotent stem cells anticipated by end 2013.
Keywords: clinical trial; commercialisation; regenerative medicine; regulation; stem cell-based therapy.