CureXcell: Cell-Based Therapy as the Future in Wound Care (Interview)

For millions of people with diabetes, even the most basic wound requires serious attention and management. Any wound not properly treated is highly susceptible to infection and can result in amputation. Worldwide, a person with diabetes loses a limb to amputation every thirty seconds.

The current standard of wound care — replete with dressings and re-dressings, gels, and other agents — is sufficiently demanding of both doctor and patient to encourage the kind of non-compliance that leads to infection, and at the extreme end, gangrene and amputation.

Cell-based Wound Treatment

While the market for wound care is crowded with companies pitching dressings, gels, grafts or vacuums, one company has developed a unique, effective, and convenient method of treating serious ulcers. Macrocure, a clinical stage biotech company has developed CureXcell, an innovative, injectable therapy that could change the way ulcerous wounds are treated.

"CureXcell is a cell-based therapy that contains a mixture of white blood cells harvested from healthy donors between the ages of 19 and 40," says Nissam Mashiach, President and CEO of Macrocure. "This mixture is injected directly into the wound bed, allowing lymphocytes, macrophages, and neutrophils to begin cellular repair and clean out bacteria and dead cells in the wound. These immune cells also stimulate the patient's own immune system to take part in the healing process."

Benefits to Patients and Doctors

Other wound treatments require a patient return to the clinic or physician at least once per week, if not more frequently, for as many as eight to ten weeks. CureXcell is administered once per month up to three months, providing a major convenience and benefit to the patient, and promoting compliance.

The product appeals to doctors as well. "Physicians want to see as many patients as possible every hour. Other wound care technology takes between 20 and 30 minutes to prepare and apply, but CureXcell requires no preparation. It is administered in five minutes, and is so simple that there is no learning curve."

CureXcell provides a needed improvement upon skin grafts and similar membranes that are frequently used in wound care, according to Mashiach. "Skin grafts contain biological elements that, when put over the wound bed, can actually feed the bacteria causing an infection. With CureXcell, we're able to bypass that layer of bacteria and go directly to the wound bed. In doing so, we're accelerating the healing process from the inside out."

CureXcell provides elements that reduce infection, and repair and remodel tissue to create a new and healthy layer of skin. Furthermore, CureXcell promotes angiogenesis at the wound site. Angiogenesis is the production of new blood vessels—crucial in the healing process.

FDA Approval

At the moment, CureXcell is only available in Israel, but the company is hoping to submit a Biologics License Application to the FDA by 2016.

"The FDA has classified CureXcell as a biologic that requires a much more rigorous path to approval than other wound care treatments and medical devices in general. For many of the products currently on the market, the bar set by the US FDA is low. The agency does not require that these companies submit any data supporting the efficacy of the product."

Doctors rely on established clinical trial data in order to determine the appropriate treatments for their patients. With most medical devices, no such data exists when the device is approved. The clinician must rely upon his or her own experience or on published case studies. Often it isn't known just how effective—or ineffective—a device or therapy truly is until it has been applied many, many times in the clinical setting on actual patients, most if not all of whom have no idea they are de facto guinea pigs.

Several thousand people in Israel have already been successfully treated with CureXcell, and the company has completed two clinical trials and has another two in progress, one that is recruiting new patients and another that has completed enrollment.

The Next Innovation in Wound Care

In the 1980s and 1990s the arrival of Negative Pressure Wound Therapy (NPWT) changed the landscape of severe wound care in the United States and beyond. Yet those things that made it a ground breaking technology back then — the application of foam and the use of a battery-powered vacuum pump — are precisely what hobble it today.

"Next year we will be doing something that no company in this field has ever done before," adds Mashiach." We will be publically disclosing the science behind how CureXcell actually works."

Not only is it unprecedented, it is a breath of fresh air and a reason for diabetic patients with severe wounds to look forward to better treatment options. As we have seen from the efforts of the United Kingdom's All Trials campaign, a physician's care is only as good as the treatment data he or she has available to them when making clinical decisions.

For more information, visit Macrocure.com

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