Stem cellⁱ research holds tremendous promise for the development of new therapies for many serious human diseases. However, at the moment, clinically proven stem cell-based treatments have been established only for very few conditions, such as hematopoietic stem cellⁱ transplants for leukemia and epithelial stem cell-based treatments for burns and corneal disorders. All other stem cell applications are experimental.

About a year ago, the International Society for Stem Cell Research formed an international task force of experts in stem cells and clinical research from 13 countries to define guidelines for the responsible development of safe and effective stem cell-based therapies for patients. I co-chaired the task force with Insoo Hyun from Case Western Reserve University, Cleveland. The Guidelines, which have now been released, define a ‘roadmap' for medical researchers and clinicians, outlining what needs to be accomplished to move stem cells from promising research to proven treatments for patients. The Guidelines also discuss social justice issues as applied to stem cell clinical translation. The new Guidelines will accelerate the translation of stem cell research into practice while addressing the associated scientific, clinical, regulatory, ethical, and social issues. They call for rigorous standards in the development of stem cell-based therapies founded on core principles - including expert evaluation and independent oversight, a thorough informed consent process to provide patients with essential information on the unique aspects of stem cell-based treatments, and transparency in reporting both positive and negative results from clinical trials. Stem cell-based products must be subjected to exhaustive evaluation in preclinical studies and to rigorous scientific and ethical review before clinical use.

The Guidelines include a Patient Handbook that will arm patients and their doctors with the information they need to make decisions about stem cell therapy. There is an urgent need to address the problem of unproven stem cell treatments marketed directly to patients. There are clinics around the world that exploit patients' hopes by offering unproven stem cell therapies, typically for large sums of money and without credible scientific rationale, oversight or other patient protections. The Guidelines establish standards that can be used to judge the legitimacy of a stem cell therapy and whether that treatment is being responsibly developed. The International Society for Stem Cell Research urges governments and regulatory bodies to enact the recommendations outlined in the Guidelines. 

Patients, medical researchers, regulators and those interested can visit the International Society for Stem Cell Research's web site to see the Guidelines, key points for patients and more information on stem cell research.