KOCHI:
Researchers of Amrita Centre for Nanosciences and Molecular Medicine (ACNSMM), Amrita Vishwa Vidyapeetham (AVVP), Kochi Campus, have developed a regenerative bone graft, NANOTEX BONE for mandible and maxilla augmentation which involves large size defects.
The research team includes Dr. Manitha Nair and Dr. Deepthy Menon (ACNSMM), Dr. Subramania Iyer, Amrita Institute of Medical Sciences (AIMS) and Dr. Manju V, School of Dentistry, under the mentorship of Dr. Shantikumar Nair, Director & Dean of Research, Amrita Vishwa Vidyapeetham. Removal of malignant tumor in the oral cavity can cause substantial functional and cosmetic defects of the jaw and cheekbones which also prevents insertion of dental implants required to help patients chew and eat normal food. Amrita’s Nanotex Bone is the solution to these problems.
The current method is to replace the diseased bone with a bone taken from another part of the patient’s body. Titanium dental implants will also be placed on the reconstructed bone to fully reconstruct the oral cavity. A main drawback of using patients’ bone is the collateral damage from significant wound and loss of bone in a remote site. No suitable synthetic materials solution is available to avoid use of remote site bone from the patient itself.
This problem has been solved by the newly invented Amrita Nanotex bone which is a perforated synthetic graft (Class D medical device) that not only is strong enough to accept dental implants but also helps natural bone to regenerate so that the patient is eventually left will real natural bone with no synthetic implant at all. The advanced innovative material is a natural fibrous nanocomposite. It contains silica- nanohydroxyapatite-gelatin reinforced with electrospun fibrous nanoyarns.
Experiments in rabbits and pigs showed that mandibular defects could be fully regenerated to normal healthy bone within three to six months. Dr. Manitha Nair of ACNSMM and Dr Subramania Iyer of AIMS, Kochi, has received a Department of Biotechnology BIRAC (Biotechnology Industry Research Assistance Council) grant to undertake a GMP (Good Manufacturing Practice) manufacturing scale-up research for the product and to conduct a pilot clinical trial of the graft in patients with mandibular defects. The team is expecting to initiate the clinical trials in 2022.
ACNSMM has established a clean-room GMP facility in Amrita Hospital campus that is undergoing ISO certification. This is the first time that ISO 13485 is being implanted in an Academic research Institute or University for doing clinical trials.
