Cipla announced that its partner Stempeutics Research has secured regulatory approval from the Drug Controller General of India (DCGI) for the launch of Stempeucel, a cell therapy for the treatment of critical limb ischemia (CLI), in India.
Stempeucel has been indicated for the treatment of the condition caused by Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease.
According to Cipla, Stempeucel is the first allogeneic cell therapy product to have been approved for commercial use in India and the first stem cell product to be approved across the world for the treatment of critical limb ischemia.
Cipla, as per the agreement signed with Stempeutics Research, holds exclusive rights for the marketing and distribution of the cell therapy in India by making use of its distribution strengths across the country.
CLI is a progressive type of peripheral arterial disease arising from a severe blockage in the arteries, which leads to reduced blood flow. This could cause the development of sores and wounds in legs and feet with a high risk of limb amputation, said Cipla.
Umang Vohra – Managing Director and Global CEO of Cipla said: “Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs and alleviate suffering. We are pleased to see that our decade-long partnership with Stempeutics has achieved a significant milestone.
“CLI is a serious and painful condition that impacts patients worldwide and we are happy that we are able to introduce this stem cell therapy in the country at an affordable cost.”
Stempeucel is said to have been designed for boosting the body’s limited capability in restoring blood flow in ischemic tissue. It is claimed to be derived from allogeneic pooled mesenchymal stromal cells, which are separated from the bone marrow of healthy, adult voluntary donors.
BN Manohar – MD and CEO of Stempeutics Research said: “Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our 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.”