Stempeutics Research, a group company of Manipal Education and Medical Group recently announced that the United States Patent and Trademarks Office (USPTO) has issued notice of allowance to grant the US patent for ‘Management of Critical Limb Ischemia (CLI) using Pooled Mesenchymal Stromal Cell product Stempeucel. Stempeucel for the treatment of CLI is a breakthrough treatment option which directly addresses the rootcause of the disease, unlike other drugs that typically treat the symptoms and not the disease itself.
Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. The company’s proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories.
CLI is a progressive form of peripheral arterial disease that blocks the arteries in the lower extremities, resulting in reduced blood flow. It is a debilitating disease which affects patients with severe pain in the feet or toes. Insufficient supply of blood flow results in the development of sores and wounds in legs and feet. If left untreated, patients may finally have to undergo the amputation of the affected limb as the the last treatment option. In the US, the most common current treatments for CLI are characterised by high rates of primary amputations, multiple procedures and high rates of procedure-related complications. In such cases, the disease not only affects the quality of life, but also increases the economic burden of patients.
Commenting on the US patent, B N Manohar, CEO, Stempeutics said, “This very important patent comes at the right time, just ahead of our planned PreIND meeting with US FDA. The patent being granted by USPTO is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work, and underscores the global leadership in allogeneic, pooled MSC technology. We believe that the Stempeucel product is a game-changer offering an advanced therapeutic treatment for millions of patients suffering from this dreadful disease.”
Professor Polani Seshagiri, a Stem Cell and Developmental biologist from the Indian Institute of Science-Bengaluru, said, “I am impressed with the scientists working at the cutting-edge stem cell biotechnology at Stempeutics. In an industry that demands constant technological and scientific advances, a robust patent portfolio covering core innovations strengthens company’s competitive edge. Stempeutics through its research innovations is demonstrating a firm commitment in bringing new generation of stem cell-based biologics in order to address unmet medical needs.”
Stempeutics is currently conducting a Phase 4 trial for CLI due to Buerger’s Disease and a Phase 3 trial for CLI due to Atherosclerotic Peripheral Arterial Disease in India.