Key Points
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Stem cell therapy from India gets a global boost as Manipal Group-backed Stempeutics partners with Tokyo-listed Medinet for commercialisation in Japan.
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Stem cell therapy product Stempeucel will be developed and marketed in Japan for Chronic Limb Threatening Ischemia (CLTI), pending PMDA approval.
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Stem cell therapy manufacturing will continue in India at Stempeutics’ Bengaluru facility, ensuring quality and cost efficiency for global use.
Stem Cell Therapy: India’s Stempeutics Expands to Japan
Stem cell therapy has taken a major leap forward as Manipal Group-backed Stempeutics Research signs a landmark licensing agreement with Tokyo-listed Medinet. The deal marks the first time a Made-in-India stem cell product will be developed and commercialized in Japan. The therapy, called Stempeucel, is designed to treat Chronic Limb Threatening Ischemia (CLTI) — a severe and life-altering form of peripheral artery disease.
Under the agreement, Medinet will take responsibility for developing and commercializing the product in Japan, subject to clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) — Japan’s regulatory authority. Stempeutics, meanwhile, will receive an upfront payment from Medinet, followed by milestone-based payments and royalties if Medinet exercises its option to license Stempeucel permanently.
This collaboration highlights India’s growing role in the global regenerative medicine industry, with Stempeutics positioned as a pioneer in delivering high-quality, consistent, and scalable stem cell therapy solutions. The partnership with Medinet gives Stempeutics access to Japan’s advanced healthcare ecosystem, where the demand for regenerative treatments is steadily rising.
Stem Cell Therapy: What Makes Stempeucel Unique
The focus of this partnership, Stempeucel, is not just another biotech product — it’s the result of years of cutting-edge research in stem cell therapy and regenerative medicine. The treatment is derived from pooled mesenchymal stromal cells (MSCs) obtained from healthy donors. Through a proprietary process developed by Stempeutics, these MSCs are pooled and standardized, which increases their immune-modulatory power, therapeutic consistency, and clinical effectiveness.
This technology gives Stempeucel a strong competitive advantage in the global cell therapy market, where product consistency and immune safety remain key challenges. The therapy targets Chronic Limb Threatening Ischemia (CLTI) — a condition caused by restricted blood flow to the limbs due to blocked arteries. In severe cases, CLTI can lead to ulcers, gangrene, or even amputation. Traditional vascular treatments only succeed in about 25% of patients.
Stem cell therapy using Stempeucel aims to change that by restoring blood flow in damaged tissues through anti-inflammatory and angiogenic mechanisms — essentially helping the body form new blood vessels and heal ischemic areas. Clinical studies so far suggest that the therapy can reduce pain, promote wound healing, and potentially prevent limb amputation in patients with advanced CLTI.
Stem Cell Therapy: India to Manufacture, Japan to Market
A key aspect of this collaboration is that manufacturing will remain in India, while Medinet takes charge of regulatory and commercial operations in Japan. Stempeutics will produce the product at its state-of-the-art cGMP (Current Good Manufacturing Practice) facility in Bengaluru, ensuring that international standards of quality and safety are maintained. The batches will then be exported to Japan for clinical trials and later for commercial distribution once regulatory clearance is secured.
This arrangement represents a model of international cooperation in stem cell therapy — combining India’s cost-effective innovation with Japan’s strong healthcare infrastructure and regulatory expertise. While financial details of the deal remain undisclosed, industry analysts suggest that this move could open up a new revenue stream for Stempeutics and attract more global collaborations for Indian biotech companies.
The partnership also strengthens India’s position in the global biotech value chain. As regenerative medicine continues to evolve, Indian firms like Stempeutics are proving that innovation and affordability can go hand in hand. By keeping production in India, the company ensures control over quality and scalability, while giving Japan access to a reliable and effective stem cell product.
Stem Cell Therapy: A Step Forward for Regenerative Medicine
The success of this partnership could redefine the future of stem cell therapy not only in India but globally. For patients suffering from CLTI — a condition that often leaves them with limited options — this could mean a new lease on life. With its scientific credibility and clinical promise, Stempeucel is poised to become a benchmark for future stem cell treatments developed in India and exported worldwide.
Experts believe this agreement demonstrates the growing maturity of India’s life sciences ecosystem. By leveraging innovation, regulatory compliance, and international collaboration, Indian firms are increasingly capable of producing therapies that meet the highest global standards. This deal could also pave the way for future partnerships between Indian biotech startups and foreign pharmaceutical companies.
In the long term, stem cell therapy may move from being a niche treatment to a mainstream medical option, especially for chronic conditions like CLTI, diabetes-related vascular issues, and neurological disorders. The collaboration between Stempeutics and Medinet is not just a commercial transaction — it’s a signal that India’s scientific innovation is ready to compete and collaborate on a global scale.
