The first indigenously developed tissue engineering scaffold from mammalian organs, an animal-derived Class D Biomedical Device that can rapidly heal skin wounds at low cost with minimum scarring, has received approval from the Indian Drugs Controller.
With this, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institution of the Department of Science and Technology (DST), became the first institution in the country to develop Class D medical devices that satisfy all statutory requirements of the Central Drugs Standard Control Organisation, Government of India.
The concept of using animal-derived materials as advanced wound care products is not new. However, indigenous technology was so far not available for fabricating quality products that satisfy the requirements of the Drugs Controller General. Therefore, such products were imported making them expensive.
Researchers of the Division of Experimental Pathology in the Biomedical Technology Wing of the institute developed an innovative technology for preparing tissue engineering scaffolds from mammalian organs.
Investigations conducted in the division in the past 15 years under the leadership of Prof. T. V. Anilkumar decellularised pig gall bladder and recovered extracellular matrix.
Membrane forms of the scaffold, identified as Cholederm, healed different types of skin wounds including burn and diabetic wounds in rat, rabbit, or dog faster than similar products currently available in the market with minimal scarring as proved by several in-depth laboratory investigations focusing Type I and Type III collagen.
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.
