India has finally got its indigenously-made scaffold from mammalian organs, an animal-derived product that can rapidly heal skin wounds at low-cost with minimum scarring. Developed by a team of scientists led by Professor TV Anilkumar from the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institution of the Department of Science and Technology (DST), the medical product ‘Cholederm’ has been given approval from the Drug Controller General of India (DCGI).
Though the concept of using animal-derived materials as advanced wound care products is not new, indigenous technology was so far not available for fabricating quality products that satisfy the requirements of the DCGI. It is also hoped that this will help cut down import bill as so far the product is being purchased from abroad. It is expected that with the introduction of Cholederm to the Indian market, the treatment cost can be reduced from Rs 10,000 to Rs 2,000- making it more affordable to the common man. “Membrane forms of the scaffold, identified as Cholederm, healed different types of skin wounds including burn and diabetic wounds in rats, rabbits, or dogs faster than similar products currently available in the market with minimal scarring as proved by several in-depth laboratory investigations focusing on Type I and Type III collagen,” said an official from the DST.
The team unravelled the probable mechanism of the healing reaction and showed that the graft-assisted healing was regulated by anti-inflammatory (pro-regenerative) M2 type of macrophages. Indeed, the scaffold modulated or mitigated the scarring reactions in subcutaneous, skeletal muscle, and cardiac tissues.
“Considering the stringency of the compliance requirements for Class D Medical Devices as per the 2017-Medical Device Rules and the general belief among stakeholders that development of animal-derived Class-D Medical Devices is not practical in India, this is a milestone achievement for the Institute, especially the research team as well as Alicorn Medical,” said Dr Harikrishna Varma, the Head Biomedical Technology Wing of the institute.
The research has been published in the journal Comparative Medicine. The scientists also said that usage of the gallbladder of pigs, normally a slaughterhouse waste without any monetary value in a highly value-added raw material for the biopharmaceutical industry can boost income of the pig farmers.
However, as the application of membrane forms of the scaffold for treating cardiac injury was found to be cumbersome, the scientists are developing injectable gel formulations of the scaffold that permits transvenous on-site delivery of the scaffold and for surface modification of polymeric medical devices.