Hyderabad: In a significant achievement for India’s biotechnology sector, Tulsi Therapeutics, a startup incubated at ASPIRE-BioNEST at the University of Hyderabad, has announced the world’s first successful animal trial of a novel stem cell-exosome combination therapy for chronic liver failure.
The investigational product, Tulsi-28X, is a groundbreaking regenerative therapy derived from Wharton’s Jelly mesenchymal stem cells and their native exosomes. It’s a combination that has never been tested in any animal model worldwide. Although conceptualised in the United States, the platform was developed in India through three years of intensive research at ASPIRE-BioNEST.
The preclinical trial, conducted in collaboration with global experts including Dr. Naga Chalasani (Indiana University, USA) and Dr. Ajay Duseja (PGIMER, Chandigarh), demonstrated 100% of the animals treated with Tulsi-28x showed reversal of liver fibrosis (indicating liver regeneration) resulting in zero deaths, compared to only 14% reversal (p<0.001) and 43% deaths (p<0.0066) in the untreated control group.
“This is a significant milestone for India’s biotech industry,” said Dr. Sairam Atluri, Founder & CEO of Tulsi Therapeutics. “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 prestigious AASLD 2024 Liver Conference in San Diego and accepted for publication in the Journal of Regenerative Medicine.
Tulsi Therapeutics is recognised as the world’s first biotech company developing a dual stem cell–exosome biologic. Tulsi-28X works by secreting regenerative proteins and growth factors, stimulating the repair of diseased liver tissue.
“We are committed to developing world-class yet affordable regenerative solutions,” said Dr. Ravi Bonthala, Chief Scientific Officer, Tulsi Therapeutics. “Our next step is to take Tulsi-28X into human clinical trials in collaboration with Nizam’s Institute of Medical Sciences (NIMS).”
Chronic liver failure remains a serious public health concern in India, contributing to nearly 20% 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 Prof. B.J. Rao, Vice Chancellor, University of Hyderabad. “It reflects the power of science, policy, and startup synergy.”
“Tulsi Therapeutics’ achievement is a proud moment for all of us at ASPIRE-BioNEST,” said Dr. Anil Kondreddy, CEO, ASPIRE-BioNEST. “It reflects our mission to nurture science-led innovation with real-world impact. Being rooted in the University of Hyderabad gives us the strength of academic excellence, and it’s incredibly fulfilling to see this ecosystem support a global-first breakthrough in regenerative medicine. This is precisely the kind of outcome we work to enable.”
