ACell, Inc., a leading regenerative medicine company focused on the development, manufacturing and commercialization of tissue repair products, today announced it has initiated, with multiple patients enrolled, a U.S. post-market clinical trial (NCT01858545) comparing the efficacy of MatriStem® to a leading cellular scaffold, Dermagraft®, for the treatment of patients with diabetic foot ulcers (DFUs) that failed to adequately heal following initial standard of care therapy. The randomized, controlled trial will measure device efficacy, cost effectiveness and long-term ulcer recurrence, among other data points.
The single-blind, two-arm study will use independent evaluators to examine outcomes of diabetic foot ulcers treated with standard of care plus either MatriStem MicroMatrix (particles) and MatriStem Wound Matrix (sheets) – or Dermagraft.
The primary endpoint of the trial is the incidence of complete wound closure at eight weeks post-treatment, with secondary endpoints including rate of wound healing and quality of life assessment. Adults with DFUs considered for treatment in the study must demonstrate an inadequate response to initial standard of care therapy and then will receive up to eight weeks of treatment with MatriStem or Dermagraft. With eight sites across the United States, the multi-center trial is expected to enroll a total of 102 patients.
Jim DeFrancesco, Chief Executive Officer and Board Director, said, "The initiation of our post-market, head-to-head study is a tremendous milestone for ACell as we hope to demonstrate the effectiveness of MatriStem devices in complete wound closure in patients with hard to treat diabetic foot ulcers. We look forward to completing enrollment of the trial, with the ultimate goal of broadening the use of MatriStem device solutions and expanding reimbursement for currently-approved devices to benefit a wider range of patients in need within the wound care setting."
One Principal Investigator said, "Following the lengthy screening process, we are excited to take the next step in the study as we believe there is an immediate need for a regenerative wound care therapy that completely repairs diabetic foot ulcers by restoring normal site-appropriate tissue where scarring would typically be expected and where competitive therapies have not been effective."
DFUs are open sores or ulcers on the feet that will not heal or keep returning in people with diabetes and can severely compromise a patient's quality of life.
About 1.3 million people are afflicted with DFUs annually in the United States.
MatriStem products have received multiple 510(k) clearances from the FDA and are indicated for wound management including use for pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds and trauma wounds, and for the reinforcement of soft tissue where weakness exists in urological, gynecological and gastroenterological anatomy.
ACell, Inc. offers the next generation of regenerative medicine through the development and commercialization of unique extracellular matrix products to repair and remodel damaged tissues in a broad range of applications. Its patented MatriStem ECM medical devices maintain and support a healing environment through constructive remodeling and are available in particle and sheet forms for the treatment of acute wounds and various surgical procedures. For more information, visit
www.acell.com.
About ACell, Inc.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacturing and commercialization of tissue repair products. Its medical devices are cleared for a variety of indications and are marketed under the brand name "MatriStem." A privately held company, ACell produces MatriStem at its full scale manufacturing facilities in Columbia, MD and Lafayette, IN, and markets its products to physicians in the U.S. through a national direct sales force. For more information, call (800) 826-2926 or visit
www.acell.com.
About MatriStem®
MatriStem Products are porcine-derived extracellular matrix (ECM), essential structures that maintain and support a healing environment through constructive tissue remodeling. MatriStem contains the basement membrane of porcine urinary bladder tissue, or urinary bladder matrix (UBM).
UBM is a layer of tissue that is a critical component of constructive tissue remodeling. It provides MatriStem with several distinguishable characteristics, including the ability to facilitate the body's own regenerative capabilities and help restore normal site-appropriate tissue while avoiding scar tissue formation; the ability to be used "off-the-shelf" and stored at room temperature, with an approximate two year shelf life; and superior ease-of-use characteristics. MatriStem products are indicated for use in a wide range of regenerative and tissue repair applications and come in a range of sizes and thicknesses. It is the only ECM of its kind available in powder form. It has been cleared for use in general surgery, gynecological surgery and a wide range of wounds, including diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure, surgical, and tunneled wounds. Refer to Instructions for Use (IFU) supplied with each device for indications, contraindications, and precautions. All MatriStem devices are made in the USA.
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