Amrita Vishwa Vidyapeetham gets CDSCO nod for world’s first synthetic jaw-bone graft

The clinical trial will be conducted on ten patients over two years

Amrita Vishwa Vidyapeetham has got landmark approval from the Central Drugs Standard Control Organization (CDSCO) for conducting 

pilot clinical trial for a novel bone graft developed jointly by Amrita School of Nanosciences, Amrita School of Medicine and Amrita School of Dentistry, Kochi. The project was funded by the Dept of Sciences and Technology, Govt of India, in the initial lab phase and then by 

Biotechnology Industry Research Assistance Council (BIRAC) for the translational large animal testing and regulatory testing phases.

The synthetic bone graft, named Nanotex Bone, provides a first-of-its-kind solution in the world for patients who lose part of their lower jaw (mandibular bone) due to cancer, injury, or trauma. The product, patented by Amrita Vishwa Vidyapeetham, also accepts tooth implants, enabling patients to lead a close-to-normal life even after losing a portion of their oral cavity bone. The clinic trial, that entails testing on ten patients, will be conducted at Amrita School of Medicine and Amrita School of Dentistry, Kochi. It is expected to be completed in two years. This is the first time that a university in India has innovated a medical product and taken it from lab research to a potentially successful medical application on its own.

Said Dr Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences & Molecular Medicine, Amrita Vishwa Vidyapeetham, who is spearheading the Nanotex Bone project, “We are the first and only university in India to develop a medical implant and get approval from the Government for testing on humans, with an in-house established ISO-certified GMP facility. This GMP has clean-room processing lines for implant and oncology products where the test products can be manufactured. No other educational institution in India has established a GMP facility for the manufacture of medical implants and nanomedicines, and none is directly associated with a hospital like we are with the 1,300-bed Amrita Hospital in Kochi. This is what makes Amrita Vishwa Vidyapeetham unique.” 

Said Dr Subramania Iyer, Professor & Chairman of Plastic & Reconstructive Surgery and Head & Neck Surgery at Amrita School of Medicine, Kochi, who is renowned for conducting India’s first-ever hand transplant in India, “The development of Nanotex bone graft and bringing it up to the clinical trial was a journey that took us ten years. The product, which can be used for mandible augmentation, will be immensely helpful for 50-60 per cent of patients with jaw cancer. It will also be tremendously useful for patients with oral cancer, which is responsible for 25 per cent of all cancer-related deaths in India, as well as for road accident victims who require facial reconstruction. The method will not add any significant cost to the treatment of patients but immensely improve their quality of life.”

The team involved in developing Nanotex Bone comprises several Amrita scientists from various specialities. From the technology side are Dr Manitha Nair, Dr Deepthy Menon and Dr Shantikumar Nair from the Amrita School of Nanosciences. From the medical side, the clinical scientists involved include Dr Subramanyam Iyer from the Amrita School of Medicine and Dr Manju Vijaymohan from the Department of Prosthodontics and Implantology, Amrita School of Dentistry.