Draft of Iranian National Guideline for Cell Therapy Manufacturing.

Cell therapy, a promising method for treatment of incurable diseases, has been moving fast from basic research laboratories to clinical practice in recent years. Defining clear and strict regulations for manufacturing of cell therapy products in clinical applications is the best way to give assurance to the public sector for safe usage, harmonizing research projects, and placing barriers for unqualified products from entering this market. To achieve this goal, the Iranian Council for Stem cell Science and Technologies sponsored a project in 2013 to develop a national cell therapy guideline for research and clinical trials. To prepare the preliminary guideline, a comprehensive literature and document review was performed by an expert team. The draft was subsequently revised and approved in May 2014 by a large group of experts who were practically involved in basic and clinical fields of regenerative medicine. The final guideline covered all aspects of cell manufacturing, including ethical issues, manufacturing process, quality controls, transportation, harvesting, storage, and release of cell-based products. The optimal infrastructure of the cell manufacturing facility as well as the eligibilities of man-power working in the facility were also described. After adoption in the Council, the guideline was sent to the Ministry of Health and Medical Education for confirmation and final approval. In this report, we introduce the main topics and mention some of the important items of this guideline. The complete draft of the guideline is available as a supplement in this issue.