Tulsi Therapeutics Achieves 100% Liver Regeneration in World's First Stem Cell-Exosome Therapy Trial
核心洞察
Tulsi Therapeutics (搜索) completed the world's first successful animal trial of a novel stem cell-exosome combination therapy for chronic liver failure, achieving 100% liver fibrosis reversal with zero deaths.
The investigational product Tulsi-28X (搜索), derived from Wharton's Jelly mesenchymal stem cells and their native exosomes, represents a first-in-class regenerative therapy never before tested in any animal model worldwide.
Results showed dramatic efficacy compared to controls, with only 14% reversal and 43% deaths in untreated animals, positioning the therapy as a potential paradigm shift for liver disease treatment.
Tulsi Therapeutics (搜索), a startup incubated at ASPIRE-BioNEST (搜索) at the University of Hyderabad (搜索), has announced completion of what it calls the "world's first successful animal trial" of a novel stem cell-exosome combination therapy for chronic liver failure. The preclinical results demonstrate unprecedented efficacy, with 100% of treated animals showing complete reversal of liver fibrosis and zero mortality.
The investigational product, Tulsi-28X (搜索), represents 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. The therapy works by secreting regenerative proteins and growth factors that stimulate repair of diseased liver tissue.
Breakthrough Preclinical Results
The preclinical trial, conducted in collaboration with global experts including Naga Chalasani from Indiana University and Ajay Duseja from PGIMER Chandigarh, demonstrated remarkable efficacy outcomes. All animals treated with Tulsi-28X (搜索) showed reversal of liver fibrosis, indicating liver regeneration, with zero deaths recorded in the treatment group.
In stark contrast, the untreated control group showed only 14% reversal (p<0.001) and experienced 43% mortality (p<0.0066). These statistically significant differences highlight the potential therapeutic impact of the dual stem cell-exosome approach.
"This is a significant milestone for India's biotech industry," said Sairam Atluri, Founder and CEO of Tulsi Therapeutics (搜索). "ASPIRE-BioNEST (搜索) 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."
Addressing Critical Medical Need
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 option, Tulsi-28X (搜索) represents a potential paradigm shift in therapeutic approaches.
The therapy utilizes exosomes—tiny, nano-sized, bubble-like structures released from cells that act as inter-cellular messengers—combined with mesenchymal stem cells to promote tissue regeneration. According to the company, Tulsi Therapeutics (搜索) may be the world's first biotech company developing a dual stem cell-exosome biologic.
Development and Next Steps
While conceptualized in the United States, the platform was entirely developed in India through three years of intensive research at ASPIRE-BioNEST (搜索). The key results were presented at the AASLD 2024 Liver Conference in San Diego and have been accepted for publication in the Journal of Regenerative Medicine.
"We are committed to developing world-class yet affordable regenerative solutions. Our next step is to take Tulsi-28X (搜索) into human clinical trials in collaboration with Nizam's Institute of Medical Sciences," said Ravi Bonthala, Chief Scientific Officer at Tulsi Therapeutics (搜索).
Innovation Ecosystem Impact
The breakthrough highlights India's growing capabilities in biotechnology innovation. "This milestone highlights how India's innovation ecosystem—anchored by institutions like the University of Hyderabad (搜索) and enabled by BIRAC and incubators like ASPIRE-BioNEST (搜索)—is capable of delivering breakthrough global biotech products," said BJ Rao, Vice Chancellor of the University of Hyderabad.
ASPIRE-BioNEST (搜索), supported by BIRAC and the Department of Biotechnology, has mentored more than 75 deep-tech life sciences startups and was recognized as "Best Emerging Bio-Incubator" by BIRAC in 2021. The incubator's CEO, Anil Kondreddy, noted that the achievement reflects their mission to nurture science-led innovation with real-world impact.