Date: 2016-08-04
Type of information: Publication of results in a medical journal
phase: 4
Announcement: publication of results in the International Wound Journal
Company: Osiris Therapeutics (USA - MD)
Product: Grafix®
Action
mechanism: Grafix® is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors and viable cells native to the tissue. Grafix is processed using Osiris' proprietary BioSmart™ technology; it is flexible and conforming and designed for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.
Disease: complex diabetic foot wounds
Therapeutic area: Regenerative Medicine
Country: USA
Trial
details: This multicenter, open-label, single-arm study is evaluating the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone. Osiris Therapeutics partnered with CPC Clinical Research , an Academic Clinical Research Organization (CRO), who was responsible for data management and pharmacovigilance services. (NCT02260609)
Latest
news: * On August 4, 2016, Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today that the manuscript from its multicenter prospective post-market clinical trial using Grafix was accepted for publication in the International Wound Journal , is now available online and will appear in an upcoming issue of the journal.
Patients between 18 and 85 years of age with confirmed type 1 or type 2 diabetes and with chronic complex diabetic foot wounds that extended through the dermis and into the subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule were considered for this study (Protocol 310). Ulcers had to be able to accommodate up to three 5 cm x 5 cm pieces of Grafix. Patients were excluded from the trial if the ulcer had any evidence of active infection at screening. Patients received treatment with Grafix weekly for up to 16 weeks. The primary endpoint measured 100% granulation of wound by 16 weeks as determined by the investigator. Secondary endpoints included complete wound closure rates, time to 100% granulation, number of applications, and percent wound area reduction at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. 31 patients were enrolled, and 27 completed the study. The patient group had significant co-morbidity, with over 80% having hypertension, over 60% being current or former smokers, 55% having heart disease and 45% having had a previous partial amputation. The mean wound area was 14.6 cm2 with mean duration of 7.5 months, and 67.7% of patients failed advanced wound therapies prior to Grafix. For patients completing the protocol, the primary endpoint, 100% wound granulation by week 16, was met by 96.3% of patients in a mean of 6.8 weeks. Complete wound closure occurred in 59.3% (mean 9.1 weeks).
