Tulsi-28x showed reversal of liver fibrosis (indicating liver regeneration) resulting in zero deaths, compared to only 14 per cent reversal and 43 per cent deaths in the untreated control group
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Tulsi Therapeutics, a start-up incubated at ASPIRE-BioNEST at the University of Hyderabad (UoH), has announced the “world’s first successful animal trial’‘ of a novel stem cell–exosome combination therapy for chronic liver failure.
“This is a significant milestone for India’s biotech industry,” Sairam Atluri, Founder & CEO of Tulsi Therapeutics said, adding that, “ASPIRE-BioNEST provided a world-class platform that helped us translate our vision into scientific reality. While human trials are the next challenge, this study opens doors to a new class of biologics in liver disease.”
Key results were presented at the AASLD 2024 Liver Conference in San Diego and accepted for publication in the Journal of Regenerative Medicine.
The investigational product, Tulsi-28X, is a first-in-class regenerative therapy derived from Wharton’s Jelly mesenchymal stem cells and their native exosomes—a combination never tested before in any animal model worldwide. While conceptualised in the US, the platform was entirely developed in India through three years of intensive research at ASPIRE-BioNEST.
“The preclinical trial, conducted in collaboration with global experts including Naga Chalasani (Indiana University, USA) and Ajay Duseja (PGIMER, Chandigarh), demonstrated 100 per cent of the animals treated with Tulsi-28x showed reversal of liver fibrosis (indicating liver regeneration) resulting in zero deaths, compared to only 14 per cent reversal and 43 per cent deaths in the untreated control group,’‘ a release said.
As per our knowledge, Tulsi Therapeutics is also the world’s first biotech company developing dual stem cell–exosome biologic. Tulsi-28X works by secreting regenerative proteins and growth factors, stimulating the repair of diseased liver tissue.
“Our next step is to take Tulsi-28X into human clinical trials in collaboration with Nizam’s Institute of Medical Sciences (NIMS),’‘ Ravi Bonthala, Chief Scientific Officer, Tulsi Therapeutics said.
Chronic liver failure remains a serious public health concern in India, contributing to nearly 20 per cent of global liver-related deaths. With transplantation being the only current treatment, Tulsi-28X represents a potential paradigm shift.
“This milestone highlights how India’s innovation ecosystem—anchored by institutions like the University of Hyderabad and enabled by BIRAC and incubators like ASPIRE-BioNEST—is capable of delivering breakthrough global biotech products,” said BJ Rao, Vice Chancellor, UoH.
Exosomes are tiny, nano-sized, bubble-like structures (vesicles) released from cells that act as inter-cellular messengers.
Published on July 24, 2025
