Stempeutics Research, an advanced clinical stage biotech company, today announced that the European Patent Office (EPO) has granted a process patent for its novel stem cell-based drug Stempeucel.

“We have received European Process Patent for our novel stem cell drug Stempeucel. Stempeutics becomes the first company in the world to be granted an EU process patent for an allogeneic stem cell drug based on pooling technology,” a company statement said here.

Stempeucel will initially be used for the treatment of Critical Limb Ischemia (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.

CLI is a progressive form of peripheral arterial disease, which blocks arteries in the lower extremities, resulting in reduction of blood flow. It is a debilitating disease which manifests with severe unmanageable pain in the feet or toes of patients.

The technology allows more than one million clinical doses from a single set of master cell banks, which is said to be unique in regenerative medicine.

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 amputation of the affected limb.

Globally, the most common treatments for CLI are characterised by high rates of primary amputations, multiple procedures and high rates of procedure-related complications.

In severe cases of CLI, the disease not only affects the quality of life but also increases the economic burden of patients and their family.

On the EU patent, Stempeutics CEO B. N. Manohar said, “The patent granted by EPO is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores the global leadership on pooling technology of MSCs for allogeneic therapy. We believe that the Stempeucel product is a game-changer in offering advanced therapeutic treatment for millions of patients suffering from this debilitating disease.”

The Bengaluru-based Stempeutics was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into a strategic alliance with Cipla in 2009.