Aghayan Hamid Reza, Arjmand Babak, Ahmadbeigi Naser, Gheisari Yousof, Vasei Mohammad
Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular -Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
1)Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular -Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. 2)Metabolomics and Genomics Research Center, Endocrinology and Metabolism Molecular -Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Arch Iran Med. 2017 Aug;20(8):547-550.
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.
细胞疗法作为一种治疗不治之症的有前景的方法，近年来已迅速从基础研究实验室走向临床实践。为细胞疗法产品的临床应用制定明确且严格的生产法规，是向公共部门保证安全使用、协调研究项目以及阻止不合格产品进入该市场的最佳方式。为实现这一目标，伊朗干细胞科学与技术委员会于2013年发起了一个项目，以制定一项针对研究和临床试验的国家细胞疗法指南。为编写初步指南，一个专家团队进行了全面的文献和文件审查。随后，该草案于2014年5月由一大批实际参与再生医学基础和临床领域的专家进行了修订和批准。最终指南涵盖了细胞生产的各个方面，包括伦理问题、生产过程、质量控制、运输、采集、储存以及细胞产品的放行。还描述了细胞生产设施的最佳基础设施以及该设施中工作人员的资质。在委员会通过后，该指南被送交卫生和医学教育部进行确认和最终批准。在本报告中，我们介绍了该指南的主要主题并提及了一些重要条款。该指南的完整草案作为本期的补充内容提供。
