Research Projects

India is at very nascent stage in the utilization of processed human tissue for regenerative applications. Whilst blood banking is well known and established, the utilization of tissues other than blood, like bone, skin, amnion, ligament, etc., has not achieved traction. Bone tissue generated as waste from hundreds of thousands of hip/knee arthroplasty procedures across the country is discarded as waste. To indicate loss of economic value due to this waste, it must be pointed out that in North America/Europe, a minimally processed femoral head is valued up to $2500, whereas in our country, it is discarded. Even if a fraction of the tissue discarded is viable, the value of the viable, unprocessed bone tissue is in multiple tens of millions of dollars. The opportunity cost of not being able to utilize such waste is also high. India generates an enormous volume of bone tissue waste through over 1,50,000 hip and knee arthroplasties annually, which can be processed for clinical use. These discarded bone/femoral heads, rich in biologically viable. (Bone is a naturally osteoinductive and osteoconductive tissue that, when preserved and processed appropriately, retains critical proteins (e.g., BMPs, collagen) and mineral components. But it is treated as bio-waste due to the absence of structured infrastructure, regulatory clarity, and indigenous processing technologies. In contrast, countries like the U.S. and Germany process and bank such tissues, using them for orthopaedic grafting, maxillofacial surgeries, and sports injuries, creating a billion-dollar orthobiologics market. The poor utilization of waste tissue is attributed to the following reasons: a) Grossly inadequate tissue banking infrastructure b) Lack of technology/expertise needed for value-addition to tissue c) Exorbitant cost of import alternatives: However, as per news Medical Devices Rules, 2017, ortho biologics tissue of human origin are classified as Class D medical devices. In a first-of-its-kind endeavour, our team has been collecting valuable waste bone tissue from hip/knee arthroplasty procedures from hospitals since 2012-2013. Donor consent and ethical permission are taken in strict accordance with the rules. Collected bone tissues are screened and processed into an enhanced demineralized bone matrix, DBM. Transforming decalcified bone matrix into powdered form combined with natural fibroin reinforcement. The DBM based bio-ink has been prepared (in-house developed techniques, patent applied), and it has enabled the fabrication of mechanically robust extrusion-based 3D bio-printed implants with tailored structures suitable for patient-specific bone fracture repair. Computer aided design (CAD) based software’s, designs patient-specific geometries based on CT scans of fracture sites. Various mechanical and bio-efficacy tests are performed. The resultant product in vivo efficacy will be characterized and tested in vivo, in an osteoporotic rabbit model, at the collaborative hospitals and at IIT Ropar. The processed 3D-printed bone can be used to produce myriad implantable materials for diverse applications. The osteoporotic patients do not have enough bone necessary for augmentation. Despite a large domestic demand, there are no indigenously developed high-efficacy orthobiologics in India. The successful lab-scale fabrication of bone-based ortho implants gives us the confidence that we should be able to achieve success along this front. We currently stand at TRL 4 and this proposal will get us to TRL 6. Our country, with its burden of ageing and diabetic population, is undergoing rapid growth in orthopaedic procedures like revision hip surgery, oral/maxillofacial surgery, and spinal fusion will benefit immensely from a low-cost indigenous product. The processing technology can be licensed to international manufacturers.