Drugs Controller approves first indigenously developed animal-derived tissue engineering scaffold for skin wounds healing

The concept of using animal-derived materials as advanced wound care products is not new

June 13, 2023 07:02 pm | Updated 08:27 pm IST - NEW DELHI

SCTIMST has become the first institution in the country to develop Class D medical devices that satisfy all statutory requirements of the Central Drugs Standard Control Organisation. Image for representation purpose only.

SCTIMST has become the first institution in the country to develop Class D medical devices that satisfy all statutory requirements of the Central Drugs Standard Control Organisation. Image for representation purpose only. | Photo Credit: Pixabay

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. “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,” said the Central Government.

Cost-effective

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 gallbladder is not available to others and it gives a fair chance for competition in the international market.

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.

Speaking about their future plans Prof. T.V. Anilkumar said that since the application of membrane forms of the scaffold for treating cardiac injury was cumbersome, 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,’’ he said.

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