Amrita Vishwa Vidyapeetham develops world’s first synthetic jaw-bone graft, gets nod for clinical trial

During a press conference on Thursday, the doctors informed that the clinic trial, which entails testing on ten patients, will be conducted at Amrita School of Medicine and Amrita School of Dentistry, Kochi. The doctors informed that it is expected to be completed in 2 years.

jaw graft, bone graft, jaw bone graft, oral cancer, surgery, health news, pharma news,
From-left-to-right-Dr.-Subramanyam-Iyer-Dr.Manitha-Nair-Dr.-Shantikumar-Nair-Dr.-Manju-Vijaymohan-and-Dr.-Deepthy-Menon.-They-are-together-holding-the-sealed-bone-product. (Fe.com)

Amrita Vishwa Vidyapeetham announced on Thursday that it has got approval from the Central Drugs Standard Control Organization (CDSCO) for conducting a 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. The product, patented by Amrita Vishwa Vidyapeetham, can enable patients to lead a close-to-normal life even after losing a portion of their oral cavity bone, according to the doctors.

On the possibility of whether the recipient’s body may reject the graft, Dr. Subramania Iyer, Professor & Chairman of Plastic & Reconstructive Surgery and Head & Neck Surgery at Amrita School of Medicine, Kochi told Financial Express.com: “The fibula flap is one standard which we use in all the patient and through a microsurgical method we have about 90-95 percent of survival rate. Our success rate is equivalent to the world’s rate. We do such surgeries quite frequently. So, that is not an issue. But putting this implant on that and looking at the survival that’s what we are looking at.

Dr. Iyer also said that they are quite certain that rejection will not occur. Adding to this, Dr. Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences & Molecular Medicine, Amrita Vishwa Vidyapeetham told Financial Express.com: “What we have here is a synthetic graft and it is not a biological implant like taking someone else’s liver and putting into the body. Here rejection is really not the issue.”

During a press conference on Thursday, the doctors informed that the clinic trial, which entails testing on ten patients, will be conducted at Amrita School of Medicine and Amrita School of Dentistry, Kochi. The doctors informed that 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.

“We have 10 patients to be included in the sample size because this was initially assessed by the statistical significance of the number of implants versus the integration and that was our outcome measure. So, 10 as a pilot project will be sufficient as we will be placing at least three implants per patient,” Dr. Iyer told Financial Express.com.

During the press conference, Dr. Subramania Iyer, Professor & Chairman of Plastic & Reconstructive Surgery and Head & Neck Surgery at Amrita School of Medicine, Kochi, who is renowned for conducting India’s first-ever hand transplant in India also said that 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 percent 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 treatment of patients but immensely improve their quality of life,” he added.

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.

In India, oral cavity cancers account for the second-highest incidence (10.3%) of cancer 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 an increase in a number of people chewing tobacco. Considering these statistics, the development of Nanotex bone graft for mandibular augmentation is very significant and will provide hope to large number of patients who have lost part of their lower jaw, the doctors claim.

 

Get live Share Market updates and latest India News and business news on Financial Express. Download Financial Express App for latest business news.

Most Read In News Healthcare
Photos