Phase III Clinical Trial of MEBO Ointment Has Counted Down to Its Initiation in India

Background introduction: India has the second largest population in the world, about 1.2 billion. Meanwhile India is one of the biggest developing countries. The incidence of burns is quite high. In India there are around11 million burn cases annually. But the local medical treatment conditions for burns are very poor. And the main methods there are western traditional technologies of dry and excision of eschar and skin grafting surgery. It is reported that the survival rate of burn patients with TBSA over than 60% is not higher than 11%, much worsely with high incidence of scar formation, disfigurement and disability. So it is urgent for Indian government to introduce the most advanced burn treatment technology and product—Burns Regenerative Medicine and Therapy and MEBO ointment. While according to the regulations and requirement of India DCGI for medicine registration, the process of MEBO ointment registration in India requires Phase III Clinical Trial in India. Thanks to the joint efforts of MEBO Group experts and the experts from India Clinical Research office—Huclin, in last November it was successfully finished the design of clinical trial protocols, which was formally presented to India DCGI. And the protocol successfully got the one-time approval from DCGI and as well as the approval to formally initiate Phase III Clinical Trial. All these results laid a solid foundation for next step of clinical trial.