Amrita Vishwa Vidyapeetham Develops Synthetic Jaw-bone Graft
The project is funded by the Dept of Science & Technology, Govt of India and BIRAC; the clinical trial will be conducted on ten patients over a period of two years
Indian University Amrita Vishwa Vidyapeetham has got an 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 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 2 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.
“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 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 Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences & Molecular Medicine, Amrita Vishwa Vidyapeetham, who is spearheading the Nanotex Bone project.
The team involved in developing Nanotex Bone comprises several Amrita scientists from various specialties. 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.
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