Regenerative Medicine May Be More Effective for Hard-to-heal Wounds

A novel therapeutic approach involving a wound care serum made up of live white blood cells has been found to more effectively treat diabetic foot ulcers and other hard-to-heal wounds including venous leg ulcers. Macrocure Ltd, a regenerative medicine company based in Israel developed this injectable serum under the product name CureXcell and it claims that this regenerative medicine has shown a 90 percent wound reduction rate. According to the CEO of the company, the therapy requires three injections per month directly on the wound site. It is quite different from skin grafts as it requires far fewer treatments.

As per the American Podiatric Medical Association (APMA), diabetes foot ulcers (DFUs) are open sores or wounds that occur in around 15 percent of patients having diabetes. Around 6 percent of patients with DFUs will be hospitalized due to infection or other ulcer-related complications. The major issue that remains challenging in treating DFUs is developing effective wound dressings. Though many types of dressings are available, there is no proper evidence to show that one type is better than the other. Venous leg ulcers (VLUs) are shallow wounds that occur when leg veins don’t return blood back towards the heart in the manner they should and the ulcers typically form on the sides of the lower leg, above the ankle and below the calf. They heal very slowly and often recur if preventive steps are not taken.

According to a MedCity News report, CureXcell is made up of a concentrated amount of white blood cells. Macrocure’s proprietary tech uses a cell activation technology, hypo-osmotic shock, which causes cells to undergo a change in gene expression. This will increase the cells’ secretion of numerous growth factors and other biochemical factors (cytokines), which stimulate the body’s natural healing process. At this stage, the cells are in a hyper-curative mode sealing the wound better than any type of dressing. However, Macrocure is in the midst of a Phase 3 clinical trial involving more than 500 patients and the results of the studies are slated for the latter half of 2015. It is expected that the company will apply for a biologics license from the Food and Drug Administration (FDA) in 2016.

Documentation plays a great role in ensuring the effectiveness of the treatment, especially when it comes to advanced treatment. The treatment protocol actually begins with the patient’s initial visit during which a history and physical report is documented thoroughly with pertinent findings. After the laboratory tests, laboratory values including complete blood cell count, albumin, hemoglobin and basic metabolic panel are also documented. All these details are extracted from the records during the treatment.

Rather than a paper-based system or general EMR, specialty electronic medical record for wound care would facilitate effective wound care treatment due to the following reasons.

  • Provides separate templates for recording wound care details so that it is easy to extract the relevant information during times of need instead of fumbling with a number of templates within the general EMR. It is also easy to track the wounds, ensure whether they are healing and take necessary steps quickly, if the wounds are getting worse.
  • In addition to the primary wound clinician, each patient may have been attended by a diabetologist, an orthopedic surgeon or other specialists. Each of these specialists can access the necessary patient records within wound EMR in real-time, if it is supported with an interface for physicians.
  • Physicians can insert the photographs of the wound and generate a customized wound report, if necessary.