MEDINET Japan and Stempeutics Research Pvt. Ltd., part of the Manipal Education & Medical Group, have signed an option license agreement granting MEDINET the rights to potentially obtain an exclusive license for Stempeucel, a stem cell-based therapy, for the treatment of Chronic Limb-Threatening Ischemia (CLTI) in Japan.
Under the terms of the agreement, Stempeutics received an upfront payment and is eligible for additional licensing fees, milestone payments, and royalties should MEDINET exercise the option. Manufacturing of Stempeucel will take place at Stempeutics’ cGMP facility in Bengaluru, with shipments to Japan for clinical trials and commercial supply upon approval.
CLTI is a severe form of peripheral arterial disease caused by critical arterial blockages that restrict blood flow, often resulting in non-healing wounds and a high risk of limb amputation. Current vascular treatments are effective for only about one in four patients. Stempeucel aims to improve blood flow in ischemic tissue by enhancing the body’s regenerative capacity.
Developed using a patented process, Stempeucel is derived from pooled bone marrow mesenchymal stromal cells (MSCs) from healthy donors. The pooling technique, according to Stempeutics, reduces donor variability and produces cells with improved immunomodulatory properties, extended lifespan, and consistent therapeutic outcomes.
“Stempeucel has already been approved in India and used to treat over 600 patients with CLTI,” said Kanenao Kubushiro, President and Representative Director of MEDINET. “The data generated in India will support regulatory discussions in Japan, where we see significant unmet need for effective CLTI treatments.”
BN Manohar, CEO of Stempeutics, described the collaboration as a milestone for both companies: “This agreement validates our leadership in allogeneic, pooled MSC technology and brings us closer to making Stempeucel available to patients worldwide.”
Kunihiko Suzuki, Executive Fellow at MEDINET and ISCT Regional Vice President Elect (Asia), said the partnership represents a step toward broader adoption of advanced regenerative therapies. “We are bringing the next generation of biologics to address serious diseases. Stem cell therapy is poised to become a standard of care for conditions like CLTI.”
Dr. Pawan Kumar Gupta, President of Medical and Regulatory Affairs at Stempeutics, added that Stempeucel offers “a new, effective treatment option that provides hope and improved quality of life for patients facing the threat of limb amputation.
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