Regulations and ethical codes for clinical cell therapy trials in Iran
Hooshang Saberi1,2, Nazi Derakhshanrad1,2, Babak Arjmand2,3, Jafar Ai2, Masoud Soleymani4, Amir Ali Hamidieh5, Mohammad Taghi Joghataei6, Zahid Hussain Khan1, Seyed Hassan Emami Razavi2
1 Department of Neurosurgery, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran;
2 Brain and Spinal cord Injuries Repair Research Center, Tehran University of Medical Sciences, Tehran, Iran;
3 cGMP-Compliant Stem Cell Facility, Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran;
4 Department of Hematology, Tarbiat Modarres University, Tehran, Iran;
5 Department of Hematology-Oncology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran;
6 Department of Anatomy, Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran
Regulations and ethical codes for clinical cell therapy trials in Iran
Hooshang Saberi1,2, Nazi Derakhshanrad1,2, Babak Arjmand2,3, Jafar Ai2, Masoud Soleymani4, Amir Ali Hamidieh5, Mohammad Taghi Joghataei6, Zahid Hussain Khan1, Seyed Hassan Emami Razavi2
1 Department of Neurosurgery, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran;
2 Brain and Spinal cord Injuries Repair Research Center, Tehran University of Medical Sciences, Tehran, Iran;
3 cGMP-Compliant Stem Cell Facility, Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran;
4 Department of Hematology, Tarbiat Modarres University, Tehran, Iran;
5 Department of Hematology-Oncology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran;
6 Department of Anatomy, Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran
摘要 Objective: The local regulations for conducting experimental and clinical cell therapy studies are dependent on the national and cultural approach to the issue, and may have many common aspects as well as differences with the regulations in other countries. The study reflects the latest national aspects of cell therapy in Iran and relevant regulations. Methods: The following topics are discussed in the article including sources of cell harvest, regulations for cell disposal, stem cell manufacturing, and economic aspects of stem cell, based on current practice in Iran. Results: All cell therapy trials in Iran are required to strictly abide with the ethical codes, national and local regulations, and safety requirements, as well as considering human rights and respect. Adherence to these standards has facilitated the conduct of human cell therapy trials for research, academic advancement, and therapy. Conclusions: The cell therapy trials based on the aforementioned regulations may be assumed to be ethical and they are candidates for clinical translations based on safety and efficacy issues.
Abstract: Objective: The local regulations for conducting experimental and clinical cell therapy studies are dependent on the national and cultural approach to the issue, and may have many common aspects as well as differences with the regulations in other countries. The study reflects the latest national aspects of cell therapy in Iran and relevant regulations. Methods: The following topics are discussed in the article including sources of cell harvest, regulations for cell disposal, stem cell manufacturing, and economic aspects of stem cell, based on current practice in Iran. Results: All cell therapy trials in Iran are required to strictly abide with the ethical codes, national and local regulations, and safety requirements, as well as considering human rights and respect. Adherence to these standards has facilitated the conduct of human cell therapy trials for research, academic advancement, and therapy. Conclusions: The cell therapy trials based on the aforementioned regulations may be assumed to be ethical and they are candidates for clinical translations based on safety and efficacy issues.
Hooshang Saberi, Nazi Derakhshanrad, Babak Arjmand, Jafar Ai, Masoud Soleymani, Amir Ali Hamidieh, Mohammad Taghi Joghataei, Zahid Hussain Khan, Seyed Hassan Emami Razavi. Regulations and ethical codes for clinical cell therapy trials in Iran[J]. 临床转化神经科学, 2015, 1(2): 110-113.
Hooshang Saberi, Nazi Derakhshanrad, Babak Arjmand, Jafar Ai, Masoud Soleymani, Amir Ali Hamidieh, Mohammad Taghi Joghataei, Zahid Hussain Khan, Seyed Hassan Emami Razavi. Regulations and ethical codes for clinical cell therapy trials in Iran. Translational Neuroscience and Clinics, 2015, 1(2): 110-113.
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2015, Vol. 1 
