by the Union Ministry of Health.
Amrita Vishwa Vidyapeetham got a landmark APPROVAL FOR CONDUCTING PILOT CLINICAL TRIAL of a novel bone graft named NANOTEX BONE Graft developed jointly by Amrita Center for Nanosciences and Molecular Medicine (ACNSMM), Amrita Institute of Medical Sciences (AIMS) and Amrita School of Dentistry (ASD), Kochi. The approval was granted on May 17 by Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare. The project was funded by Department of Sciences and Technology in the initial lab phase and then by BIRAC, Govt. of India, for the translational large animal testing and regulatory testing phases. The product provides a first of its kind solution for patients who lose part of their mandibular bone due to cancer or trauma. The product can also accept tooth implants so that patients can lead a close to normal life after losing a portion of the oral cavity bone. The product is a first of its kind in the world and the product is patented.
This is also the first time that any university in India has developed its own medical device product and has been approved for conducting its own clinical trial by the Government of India. This has been made possible because Amrita Vishwa Vidyapeetham has established GMP (Good Manufacturing Practice) manufacturing facility with clean rooms that is ISO certified and this product will be manufactured in this GMP and then the clinical trial will be conducted in Amrita Institute of Medical Sciences and Amrita School of Dentistry. No other educational institution in India has a GMP facility for manufacturing medical implants and nanomedicines and is also directly associated with a hospital. This is the uniqueness of Amrita Vishwa Vidyapeetham.
The scientific team is a very interdisciplinary team of scientists, clinicians and technologists. On the technology side the scientists are Dr Manitha Nair, Dr Deepthy Menon and Dr Shantikumar Nair, Dean of Nanoscienes and Pharmacy, Amrita Vishwa Vidyapeetham and Director of Amrita Center for Nanosciences and Molecular Medicine; on the medical side the key clinical scientist is Dr Subramanyam Iyer of hand transplant fame from the Department of Head and Neck Cancer and Maxillofacial surgery, and Dr. Manju Vijaymohan, Department of Prosthodontics and Implantology, Amrita School of Dentistry.
The bone graft development to clinical trial was a long pathway, which took almost 10 years. This long track was completed due to the consistent effort of many outstanding students, who were involved in different stages of material development like design and development, in vitro studies, small & large animal studies, regulatory and validation studies, and GMP production.
The Amrita GMP facility is granted ISO 13485 quality management system approval to provide medical devices as per regulatory and customer requirements. This is the first time in India that an academic Institute is setting ISO 13485 for doing clinical trial investigation.
Social Relevance
The NANOTEX BONE Graft developed at Amrita can be used for mandible augmentation, wherein 50-60 % of the population affected with jaw bone cancer will be benefited due to this. The method will not add high cost to the treatment, but tremendously increase the quality of the life of patients. Oral cavity cancers account for second most incidence (10.3%) with 1,35,929 new cases and 8.8% mortality. The International agency for research on cancer has predicted that India’s incidence of oral cancer will rise to more than 1.7 million in 2035 due to increased usage of tobacco chewing. Cancer Statistics in India (2018) shows oral cancer as the leading cause of mortality in men, and it is responsible for 25% of cancer-related deaths. In addition to cancer, road traffic accidents are common in India, wherein orofacial trauma can occur, of which 50% of the population undergoes reconstruction surgery.
Report : Navya Susan Mathew
