Date: 2015-10-06
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Osiris Therapeutics (USA - MD)
Product: OTI-15-01
Action
mechanism: cell therapy. OTI-15-01 is comprised of several components known to be critical for effective wound healing including a collagen rich matrix, growth factors and neonatal fibroblasts, epithelial cells, endothelial cells, and mesenchymal stem cells (MSCs). These cell types mediate their functions in response to the local tissue microenvironment and secrete a variety of growth factors and extracellular matrix proteins that orchestrate wound healing. IND 16383 is investigating the impact of this on clinical outcomes, specifically healing rates, in patients with chronic, non-healing diabetic foot ulcers.
Disease: chronic diabetic foot ulcers
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country: USA
Trial
details: The phase III trial is designed as a randomized, controlled, blinded study, and is expected to enroll up to 224 patients in approximately 20 sites. Patients will be randomized to receive OTI-15-01 plus standard of care versus standard of care alone, which includes debridement, a non-adherent dressing, and standardized off-loading. (NCT02571738)
Latest
news: * On October 6 2015, Osiris Therapeutics announced the initiation of its Multicenter, Randomized, Blinded Study with an Open-Label Extension Option to Evaluate the Safety and Efficacy of OTI-15-01 for the Treatment of chronic diabetic foot ulcers. The phase III trial is designed as a randomized, controlled, blinded study, and is expected to enroll up to 224 patients in approximately 20 sites. Patients will be randomized to receive OTI-15-01 plus standard of care versus standard of care alone, which includes debridement, a non-adherent dressing, and standardized off-loading.
The primary endpoint is the proportion of patients with complete wound healing by week 12, with confirmation of durability of complete wound healing during two subsequent visits two weeks apart. Secondary endpoints include time to healing, week 4 wound size reduction, number of applications and overall safety, including wound specific adverse events. Patients in the control arm who receive standard of care and do not heal within 12 weeks will be able to receive active drug in an open-label crossover arm of the trial for up to 12 additional weeks. The study design was reviewed by the FDA and meets the requirements established by FDA in the 2006 guideline for Industry clinical trials for products used to treat burns and cutaneous ulcers. This protocol for OTI-15-01 is conducted under the Investigational New Drug (IND) application IND 16383
