Amrita Vishwa Vidyapeetham gets CDSCO nod for Nanotex bone graft trial

The project was funded by the Department of Sciences and Technology under the Government of India, in the initial lab phase and then by the Biotechnology Industry Research Assistance Council (BIRAC) for the translational large animal testing and regulatory testing phases, according to an official statement.

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, which 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 all the way from lab research to a potentially successful medical application on its own, the statement read.

Dr Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences and Molecular Medicine, and Amrita Vishwa Vidyapeetham, who is spearheading the Nanotex Bone project said, "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 cleanroom 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," Dr Nair stated.

Meanwhile, Dr Subramania Iyer, Professor and Chairman of Plastic and Reconstructive Surgery and Head and Neck Surgery at Amrita School of Medicine, Kochi, who is renowned for conducting India's first-ever hand transplant in India said, "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 of oral cancer, which is responsible for 25% 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," Dr Iyer added.

The feat of developing Nanotex bone graft was made possible due to the efforts of many outstanding medical students involved in different stages of material development like design and development, in-vitro studies, small and large animal studies, and regulatory and validation studies, and GMP production.

Oral cavity cancers account for the second-highest incidence (10.3 per cent) of cancer in India, with 1,35,929 new cases every year and 8.8 per cent mortality. The International Agency for Research on Cancer (IARC) has predicted that India's incidence of oral cancer will rise to more than 1.7 million in 2035 due to an increase in the number of people chewing tobacco, the statement added.