Stempeutics Research, a group company of Manipal Education and Medical Group and a Joint Venture with Cipla Group, announced today that the State Intellectual Property Office of China (SIPO) granted a process patent for its novel stem-cell based drug Stempeucel. Stempeucel will initially be used for the treatment of CLI and is a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself.
Critical Limb Ischemia (CLI) is a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting into reduction of the blood flow. It is a debilitating disease which affects patients with severe pain in the feet or toes. Insufficient supply of blood flow results into the development of sores and wounds in legs and feet. If left untreated, patients may finally have to undergo amputation of the affected limb as the last treatment option. In China, the most common current treatments for CLI are characterized 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.
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.
Commenting on the patent granted by SIPO, Mr B N Manohar, CEO of Stempeutics, said, "Stempeutics has taken an aggressive, focused and well thought-out scientific approach to understand the biology of human adult stem cells, and to harness the potential of these cells for the treatment of CLI. The efforts are realized through innovative technologies and ideas, cutting edge R&D, patentable process development, large scale manufacturing and effective clinical trial design. We believe that the Stempeucel product is a game-changer, offering an advanced therapeutic treatment to millions of patients suffering from this dreadful disease."
Mr Chandru Chawla, Head Cipla New Ventures, said, "China has a high prevalence of diabetes and consequently many suffer from ischaemic limb condition. The patent grant in China is yet another important milestone after the grant of the patent in the United States."
Stempeutics has already submitted its application to the Drug Controller General of India (DCGI) to obtain marketing authorisation approval for Stempeucel. The availability of the product in the market is subjected to DCGI approvals.