An Israeli biotech company’s cell therapy, designed to treat hard-to-heal diabetic ulcers, is now in phase 3 testing in the United States.
The company, Macrocure, reports that its product, CureXcell, demonstrated impressive success rates at Israel’s largest HMO. The Israeli trial, called a “Real Life” phase 4 trial, was conducted with 131 subjects at seven clinics operated by Clalit Health Service.
Macrocure announced the trial results recently in Atlanta at the Symposium on Advanced Wound Care. The company reported that after 24 weeks, its therapy achieved a 68 percent closure rate for diabetic foot ulcers and an 81 percent closure rate for venous ulcers. The closure rate for all ulcers was 71 percent.
Diabetic foot ulcers occur in about 15 percent of all patients who have diabetes. The wounds are a great concern because they can become infected and lead to gangrene and the need for amputation.
CureXcell uses activated white blood cells obtained from healthy young adult donor blood. The activated cells are injected directly into non-healing wounds, where they release an array of active allogeneic immune cells. These cells release necessary cytokines and growth factors that allow wounds to heal.
The product has been used to treat about 5,000 patients with various types and severities of hard-to-heal wounds in Israel. While CureXcell has received the go-ahead to be marketed in Israel, it is not yet licensed for sale in either the United States or Canada.