“We have 18 international patents granted for Stempeucel pooling technology”

Bengaluru based Stempeutics Research has received regulatory approval from the Drug Controller General of India (DCGI) for the launch of Stempeucel in India.

- Dr Manbeena Chawlahar

Indicated for the treatment of critical limb ischemia (CLI), the product is the first allogeneic cell therapy to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment. The company has partnered with Mumbai based pharma company Cipla for the marketing and distribution of the product. BioSpectrum interacted with B N Manohar, Managing Director & Chief Executive Officer, Stempeutics Research, Bengaluru to find out more about this innovative product.

What are the key highlights of Stempeucel?

The key feature of Stempeucel is that it is an on-demand, cryo-preserved, allogeneic regenerative medicine targeting unmet needs. It is physician prescribed and the drug is administered through intramuscular injections around the calf muscle region and around the site of ulcers for CLI treatment. There is a unique patented stem cell pooling technology involved. We have 57 filed patents for this product, 18 international patents granted for Stempeucel pooling technology, including United States, France, UK, Germany, Italy, China, Japan, Australia, New Zealand, Singapore, South Africa and Philippines. It is the first stem cell product with pooling technology to be classified as an Advanced Therapy Medicinal Product (ATMP) and granted Orphan Drug Designation by the European Medicines Agency (EMA) in 2015. Few other indications where this product is being explored includes an ongoing Phase 3 clinical trial for osteoarthritis and diabetic foot ulcer, ongoing Phase 1/2 study for perianal fistula due to Chron’s Disease indication; and we are starting Phase 2 COVID-19 acute respiratory distress syndrome (ARDS) study with the government support.

Please share more details about the CLI treatment procedure.