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.
In 2017, the technology was transferred to Alicorn Medical, a start-up biopharmaceutical firm in the technology incubation facility of the institute namely TIMed.
“Considering the stringency of the compliance requirements for Class D Medical Devices as per the 2017-Medical Device Rules of India 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.
In a recent research paper accepted for publication in Comparative Medicine, the team showed that the scaffold has the ability to mitigate fibrotic scarring in rats suffering an experimental myocardial infarction.
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,” said Prof. T. V. Anilkumar.