Stempeucel for Buerger's Disease Receives Limited Approval from Drug Controller of India

An effective cure for one of the most devastating disease could be in the cards as the Drug Controller of India (DGCI) has granted limited approval for manufacturing and marketing the first stem cell therapy for the treatment of Buerger's disease.

Buerger's disease is a rare life-threatening disease affecting the arteries and veins in the legs. The blood vessels could become inflamed and get blocked by small block clots, leading to reduced blood flow and amputations.

‘Drug Controller of India has granted limited approval for the first stem cell therapy �stempeucel� to treat Buerger�s disease, a rare disease affecting a million in India. ’

There is currently no cure for this disease except bone marrow transplant recommended optionally. The disease affects about a million in India.

A Bangalore-based startup company, Stempeutics have developed a therapeutic product called as "Stempeucel" for this rare disease. This treatment can enhance the body to restore blood flow in ischemic tissue by reducing inflammation and improving new blood vessel formation in the abnormal tissue.

BN Manohar, CEO Stempeutics said, "We are the first company in India to achieve such approval. It took almost nine years to develop Stempeucel for the treatment of Buerger's Disease. European Medicines Agency has classified Stempeucel as an Advanced Therapeutic Medicinal Product (ATMP) and designated it as an Orphan Drug (ODD) for the treatment of Buerger's Disease. Our goal is to globalize Stempeucel for Buerger's Disease, and the market size is approximately $1.5 billion worldwide".

Stempeutics Research is a joint venture between drug maker Cipla and Manipal Group and the company is focussed on getting full approval for their stem cell therapy by 2018. It is sold for 1.5 lakh in India.

He added, "This is a historic step and has opened the gate for stem cell therapy in India. We have now got only limited approval which means we can use it in only a specific number of patients. They have limited it to 200 patients. We have to submit the data of these 200 people to the government and prove that the drugs are safe in terms of efficacy and safety. They have also given us a limit on how much we can charge these patients which is not beyond Rs 1.5 lakh per patient. A single dose is enough. We have to complete it in two years after which we will get a full marketing authorisation and this can be fully distributed to all patients."



Source: Medindia