An advanced wound care product developed by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), named Cholederm, has won the approval of the Central Drugs Standard Control Organisation (CDSCO) as a Class D medical device.
Cholederm is a wound healing material derived from the extracellular matrix of de-cellularised gall bladder of pig and tissue engineered as membrane forms of scaffold, by the researchers at the Division of Experimental Pathology in the Biomedical Technology wing of SCTIMST.
The research team was led by T.V. Anilkumar, Scientist G (Veterinary Pathology) and Head of the Division of Experimental Pathology.
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. In 2017, SCTIMST transferred the technology to M/s Alicorn Medical Pvt Ltd, a start-up biopharmaceutical firm. However, the pandemic delayed the firm’s clearance for obtaining a manufacturing licence for commercial production and sale.
‘Milestone achievement’
Harikrishna Varma, the Head of Biomedical Technology wing, in a statement here said that given the stringent requirements that have to be met under the 2017 Medical Devices Rules, the development of animal-derived Class D medical devices was not considered to be an easy or practical proposition. The CDCSO approval for Cholederm is thus a milestone achievement for the SCTIMST and M/s Alicorn Medical Pvt Ltd., Dr. Varma said.
Though the concept of using animal-derived products for manufacturing advanced wound care material is not new, Cholederm is the first indigenously developed product to meet all regulatory requirements.
Cost-effective
The introduction of the product in the Indian market can significantly bring down the cost of this category of products, the statement said.
Researchers said that the scaffold modulated or mitigated the scarring reactions in subcutaneous, skeletal-muscle and cardiac tissues and that it had the ability to mitigate fibrotic scarring in rats suffering experimental myocardial infarction.
Since the application of scaffold to treat cardiac injuries was a cumbersome process, the team is now attempting to develop injectable gel formulations of the scaffold, according to SCTIMST.