Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

• Main Authors: Sharma A, Al Zoubi ZM
• Format: Article
• Language: English
• Published: Tsinghua University Press 2016-01-01
• Series: Journal of Neurorestoratology
• Subjects: cellular therapy; ethics; regulations; evidence based medicine; practice based evidence
• Online Access: https://www.dovepress.com/rethinking-on-ethics-and-regulations-in-cell-therapy-as-part-of-neuror-peer-reviewed-article-JN

Alok Sharma,1,2 Ziad M Al Zoubi3 1Department of Neurosurgery, Lokmanya Tilak Municipal General (LTMG) Hospital and LTM Medical College, Mumbai, India; 2NeuroGen Brain and Spine Institute, Mumbai, India; 3Jordan Orthopedic and Spinal Centre, Amman, Jordan Abstract: Ethics, regulations, and evidence-based practices form the foundation of modern medicine. However, in recent years, and particularly in reference to cellular therapy, they have become obstacles to the growth and development of this new form of treatment. Based on four important documents, it is proposed that regulatory bodies and medical associations recommend an alternate way of looking at regulations for cell therapy, so as to ensure that only safe and effective treatments are offered to patients, and that greater availability of these new treatment options is also encouraged. The four documents on which these recommendations are based are: 1) World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects; 2) The International Society for Cellular Therapy "White paper" published in 2010; 3) The Beijing Declaration of the International Association of Neurorestoratology; and 4) New legislation passed in Japan in 2014 on regenerative medicine. These recommendations are: greater permissiveness for the use of cell therapy in incurable conditions, identify legitimate cell therapy services, promote medical innovation, respect the rights of patients to choose treatments, recognize the valid compassionate use of unapproved therapies, recognize the significance of small functional gains, give importance to practice-based evidence and existing published literature, have differing regulations for the different types of cell therapies, and adapt the new Japanese legislation for regenerative medicine. Keywords: cellular therapy, stem cells, ethics, regulations, evidence-based medicine, practice-based evidence, Japan regulations, Korea regulations