What do we know of the safety and efficacy of stem cell therapeutics?
Over 50 years have passed since the discovery of hematopoietic stem cells (bone marrow transplantation to cure diseases such as leukemia), almost 20 years since the discovery of human embryonic stem cells (hESC), and 10 years since the discovery of induced pluripotent stem cells (iPS cells). There are also more than 5,000 stem cell trials ongoing in clinics globally. Despite this experience, what do we actually know about the safety and efficacy of stem cell therapeutics?
In this novel and increasingly complex stem cell space, it is perhaps a timely question to ask, especially since the regulatory assessment criteria designed for conventional medicines are not directly applicable for stem cell therapy. [Read more…]