MacroCure’s CureXcell takes white cells from healthy donors and activates them to speed up the healing process, and was shown to heal most diabetics risking a leg amputation from gangrene, afflicting 15 percent of people who get the disease.
CureXcell is injected into the wound and was tested on 5,000 patients in Israel, where it’s already been approved to treat chronic wounds, such as pressure ulcers, diabetic foot ulcers, and post-operative wounds, including deep sternal wound infection, post cesarean operation, post orthopedic surgery, and post abdominal surgeries.
Stage IV testing in 2012 showed CureXcell improving the healing of the type of ulcers that lead to many diabetics having to amputate a limb or appendage from gangrene, the company said. 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.
MacroCure said CureXcell could help the 15 percent of diabetics who eventually develop this condition. The company is currently recruiting 280 patients for a Stage 3 test for the approval process in the U.S. and Canada.
In a four-year study, CureXcell was used to heal deep sternal wound infections. Mortality was 3 percent (2/66) in the CureXcell group versus 30 percent (19/64) in the control group. The patients were from seven clinics operated by Clalit Health Service and the results were presented at the Symposium on Advanced Wound Care, in Atlanta, Georgia.
In the U.S, diabetes infects some 25 million people, 8 percent of the population, with 2 million being diagnosed each year and 7 million suffering without knowing they have the disease, according to the U.S. National Institute of Health. Nearly a quarter of the country — 79 million adults — are believed to have “pre-diabetes” because of unhealthy conditions, such as obesity.
About 1.5 million diabetics, 5 percent of diagnosed patients, suffer from Type 1 diabetes, also known as juvenile diabetes, because it is often diagnosed in childhood, and insulin-dependent diabetes, because their bodies require a daily injection of the chemical because the amount of sugar in their blood is too high.
In terms of the impact of diabetes on the healthcare system, NIH said direct medical costs total $116 billion annually, plus another $58 billion from diabetics leaving the workforce because their wounds could not cure.