Amrita Vishwa Vidyapeetham gets CDSCO nod for clinical trials of synthetic jaw-bone graft

From left to right - Dr. Subramanyam Iyer, Dr.Manitha Nair, Dr. Shantikumar Nair, Dr. Manju Vijaymohan, and Dr. Deepthy Menon, holding the sealed bone product.

Amrita Vishwa Vidyapeetham has got the 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 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.

“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,” said Dr. Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences & Molecular Medicine, Amrita Vishwa Vidyapeetham, spearheading the Nanotex Bone project.

The clinical trial, which entails testing on 10 patients, will be conducted at Amrita School of Medicine and Amrita School of Dentistry, Kochi and is expected to be completed in two years.

This project was funded by the Department of Sciences and Technology in the initial phase and then by Biotechnology Industry Research Assistance Council (BIRAC) for the translational large animal testing and regulatory testing phases.

According to the university, oral cavity cancers account for second highest incidence (10.3 percent) of cancer in India, with 1,35,929 new cases every year and 8.8 percent 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 increase in number of people chewing tobacco.