Abstract

India was amongst the first countries in the world to create a set of dedicated guidelines for stem cell therapy in the year 2002. These guidelines which were created by the Indian Council of Medical Research were comprehensive and progressive when one considers that the field was at that time in its infancy. Subsequent developments including the more recent guidelines created in the year 2007 and 2013 did not keep up with the progressiveness of the initial guidelines. In fact it would not be incorrect to state that the most recent set of guidelines (2013) is regressive and if implemented will destroy the emerging field of regenerative medicine in the country. This paper highlights the limitations and flaws in the existing guidelines and proposed regulations and makes suggestions based on published scientific data from our own clinical work, national priorities, patient requirements and global trends, which could form a basis for a review of our national guidelines and regulations. Read more...

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. Read more...

Abstract

In the last issue of this journal we had published an article 'The need to review the existing guidelines and proposed regulations for stem cell therapy in India based on published scientific facts, patient requirements, national priorities and global trends' on the need of new regulation for Stem Cell therapy in India. We had highlighted the deficiencies in the existing guidelines and suggested broad general principles on which new regulations should be framed. Worldwide countries have realized the need for newer regulations that are more permissive of stem cell therapy. Most progressive legislation is that of the USA ( REGROW Act) and JAPAN (PMD Act and ASRM), which allows conditional, fast track marketing approval for stem cell products and separate monitoring systems for cell therapies based on their risk to human life and health. The Korean Regulations have excluded minimally manipulated cells from their 'Review and authorization of Biological products'. European medical agency (EMA) has also come up with the advanced therapy medical product (ATMP) laws, PRIME (PRIority MEdicines) act and Hospital Exceptions (HE) act that are also favourable to newer therapies such as regenerative medicines. New concepts and terms that are now becoming part of the more permissive regulations are Conditional marketing approval, Risk Stratification, Post-Hoc efficacy analysis, Presumed efficacy, Patients' right to seek treatment, Distinction between cellular therapies, Distinction between a stem cell product and medical service. Read more...