· 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 SreeChitraTirunal
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.
· 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. Anilkumardecellularised 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.
· 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. Moreover, the technology for recovering extracellular matrix from the gall bladder is not available to others and it gives a fair chance for competition in the international market. In addition, the above findings made gall bladder of pigs, normally a slaughterhouse waste without any monetary value, a highly value-added raw material for biopharmaceutical industry thereby creating an additional income-generating opportunity for pig farmers.
· However, the application of membrane forms of the scaffold for treating cardiac injury was cumbersome. Therefore, the team is developing injectable gel formulations of the scaffold that permits transvenous on-site delivery of the scaffold and for surface modification of polymeric medical devices. “Further investigations in multiple species of animals are necessary to confirm the claim. If true, these observations are likely to revolutionaries the contemporary modalities of managing patients suffering from myocardial infarction.