Stem Cells and Regenerative Medicine

Stem Cells and Regenerative Medicine

Regenerative medicine has been proposed to provide in the near future cures for debilitating diseases such as diabetes, cardiovascular disease, and Alzheimer’s disease. In particular, the use of stem cells to repair damaged tissues has led to a number of clinical trials in a range of diseases. However, despite the enormous potential of stem cells for regenerative medicine, there are many hurdles to overcome to develop these therapies. Although we are able to isolate, culture expand and differentiate stem cells in vitro, the requirements for in vivo survival, proliferation and differentiation into functional tissue, are essentially unknown. In addition, we must understand the role of immune cells that may reject donor cells or trigger other immune reactions leading to failure of the therapy or even worse, death of the patient. Added to these biological issues are the regulatory requirements for conducting clinical trials and the complexities of cellular products. Many aspects of drug development including toxicology, development of potency assessment, determination of dosing and safety assessment in animal models are not readily applicable to cellular products.