The drug controller general of India (DCGI) has granted limited approval to Stempeutics Research, a joint venture between drug maker Cipla and Manipal Group for manufacturing and marketing its stem cell based biological drug Stempeucel for the treatment of Buerger’s Disease. It is India’s first therapeutic product for this rare disease, which was unaddressed by modern medicine so far.
Buerger’s Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis. With no effect treatments available till now, the patient in most case would require amputation. According to Cipla, the Stempeucel treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularisation or new blood vessel formation in abnormal tissue.