Novel bone graft developed by Amrita Vishwa Vidyapeetham gets approval for clinical trials

Amrita Vishwa Vidyapeetham, a private university, on Thursday said it has got approval for conducting a pilot clinical trial of a novel bone graft named Nanotex Bone Graft developed jointly by its three major departments of research.

Nanotex Bone 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,'' it said in a statement.

The university said the product was 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) under the Union Ministry of Health and Family Welfare, it said.

The university claimed that this is also the first time that any varsity in India has developed its own medical device product and has been approved for conducting its own clinical trial by the Government of India.

It said 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 efforts put in by many outstanding students, who were involved in different stages of material development like design and development, in-vitro studies, small and large animal studies, regulatory and validation studies, and GMP production, the university said.

The Nanotex Bone Graft developed at the university can be used for mandible augmentation, wherein 50-60 per cent of the population affected with jaw bone cancer will be benefited due to this, it said.

The method will not add high cost to the treatment, but tremendously increase the quality of life of patients.

Oral cavity cancers account for the second highest incidence (10.3 per cent) of the disease with 1,35,929 new cases and 8.8 per cent mortality, the university said.

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