Positive results from Cytomedix's AutoloGel System study for treatment of advanced, chronic wounds published

Jun 17 2010

Cytomedix, Inc. (NYSE Amex:GTF), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that positive results from a prospective study evaluating the AutoloGel™ System to treat advanced, chronic wounds was published in the June 2010 issue of Ostomy Wound Management in a peer reviewed article entitled, "Chronic Wounds Treated With a Physiologically Relevant Concentration of Platelet-rich Plasma (PRP) Gel: A Prospective Case Series." The article is available at http://www.o-wm.com/content/chronic-wounds-treated-physiologically-relevant-concentration-platelet-rich-plasma-gel-prosp.

The study's lead author is Robert G. Frykberg, DPM, MPH, Chief, Podiatry and Residency Director, Phoenix VA Healthcare System in Phoenix, Arizona. The study enrolled 49 patients with 65 chronic wounds, 35% of which had areas of undermining and 15% of which had sinus tracts/tunneling (ST/T). Pressure ulcers, venous ulcers and diabetic foot ulcers were the most prevalent wounds. The mean previous wound duration without healing was 47.8 weeks. Mean baseline wound area was 19 cm² and volume was 36.2 cm³. The study was conducted in various care settings including eight long-term acute care hospitals and three outpatient foot or wound clinics.

The study concluded that treatment with physiologically relevant concentrations of PRP derived from the AutoloGel System "showed the product can be utilized by healthcare providers in various healthcare settings to restart the healing process in complex chronic wounds, even wounds recalcitrant to other treatments, and in patients with advanced age, compromised lab values, and co-morbidities. Sixty-three (63) of 65 (97%) wounds responded with reductions in area, volume, undermining, and/or ST/T in a mean of 2.8 weeks with 3.2 treatments. These results have important clinical implications and suggest this treatment can reverse the non-healing trend in chronic wounds."

The study defined clinical relevance as the potential of a therapy to provide positive results in a group of patients, the magnitude of the response, the length of time, and the number of treatments to achieve the response. It also noted that in a healthcare system trying to save time and money with the best impact of a modality, the concept of clinical relevance assists clinicians in determining efficient treatment options.

In an average of 2.8 weeks with a mean of 3.2 AutoloGel treatments, the proportion of wounds responding and the amount of the response for all etiologies included: in 58 of 65 (89%) wounds, volume decreased 62%; in 55 of 65 (85%) wounds, area decreased 51%; and in 23 of 23 (100%) of the wounds with undermining and/or ST/T, wound size was reduced 78% and 46%, respectively.

Commenting on this study, Martin P. Rosendale, President and CEO of Cytomedix, Inc., said, "These data further confirm our thesis that providing physiologically relevant concentrations of PRP is critical to restarting the body's natural healing processes, as was clearly demonstrated with the AutoloGel System in these previously non-healing, chronic wounds."

"We are especially pleased that the AutoloGel System provided a rapid reduction in wound size for nearly all of these chronic wounds, offering a safe and effective treatment for patients suffering from long-term, non-healing wounds. Chronic wounds are a growing medical concern with few treatment options. We firmly believe the concept of clinical relevance to be an important aspect of this data set. In a variety of care settings, a critical element to effective and successful wound management is the prompt initiation of a positive wound healing trajectory. By offering physiologically relevant concentrations of PRP and effectively harnessing the body's natural healing processes, the AutoloGel System can have a positive and significant impact in short treatment windows," he added.

SOURCE Cytomedix, Inc.