Cytomedix Reports Publication of Positive Autologel Wound Healing Data in Ostomy Wound Management (CMXI)

Cytomedix, Inc. (OTCBB: CMXI) is a biotechnology company developing advanced tissue regeneration technologies. Our primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Our commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGelTM System (“AutoloGel”). 

The Company has announced the publication of positive clinical data regarding its AutoloGel™ System in the April 2012 issue of Ostomy Wound Management in an article entitled, "A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program." 

According to the press release,

"The purpose of this retrospective study was to capture evidence-based treatment outcomes in limb salvage patients with complex ulcerations treated in Japanese wound care centers using AutoloGel platelet-rich-plasma gel (“PRP”). The study involved 40 wounds in 39 severely compromised patients with comorbidities of diabetes mellitus (DM), lower limb arteriosclerosis, ischemia and infection. The majority of the patient population (34 or 85%) had DM and 24 of those also had arteriosclerosis. Diabetic foot wounds were Wagner Grade lll (77%) (deep ulcers with cellulitis or abscess formation, often with osteomyelitis) and lV (23%) (localized gangrene). Skin perfusion pressures of less than 40 mm Hg were recorded in 25 or 63% of the patients, and less than 30 mm Hg in 20 or 50% of the patients indicating critical limb ischemia which can impair healing. The study included a run-in period of 75.3 days on average, during which revascularization and/or debridement along with standard-ofcare therapy with advanced modalities were administered."

The Key Findings of the study are as follows:

• During the run-in period, no wounds healed and wound measurements for area, depth and volume actually increased
• Following AutoloGel treatment, 32 or 83% of wounds healed in an average of 145.2 days (p=0.00002) using an average of 6.1 treatments
• Mean changes over time in area (p=5.0x10-7), depth (p=1.2x10-6), and volume (p=7.3x10-5) were all statistically significant

Dr. Chugo Rinoie, DPM, ABPO, CWS, Chief of Podiatric Surgery, Wound Healing Center, Methodist Hospital of Southern California, Arcadia, CA, Medical Director, Millennia Wound Management, Inc, Los Angeles, CA, as well as a corresponding author of the publication, noted,

"These data demonstrate that autologous PRP gel can be used to heal long-standing, chronic Wagner III and IV wounds in patients with diabetes and moderate-to-severe peripheral arterial disease whose skin perfusion pressure indicates poor healing prognosis and probable limb amputation. Further, the associated wound care database now comprises over 200 wounds from Japanese AutoloGel patients."

Martin P. Rosendale, Chief Executive Officer of Cytomedix, commented, 

“We are delighted to have this compelling data published in a peer-reviewed journal as this study demonstrates that patients with chronic diabetic wounds and compromised arterial flow can heal and avoid limb amputation with AutoloGel treatment. These data support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care. The complexity and comorbidities associated with these wounds would have excluded them from any randomized controlled trial making this real world comparison study even more compelling. We believe data such as these strongly support our case for a positive National Coverage Determination from the Centers for Medicare & Medicaid Services to cover autologous PRP gel for the benefit of the various stakeholders interested in improving clinical wound care outcomes while lowering overall costs.”

Dr. Rinoie will be presenting these positive data in a poster presentation at the upcoming Symposium on Advanced Wound Care-Spring 2012 being held in Atlanta, Georgia from April 19-22, 2012.

 Read more at Cytomedix.com. 

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