Successful Phase 1/2a Trial for Treating Chronic Hard to Heal Diabetic Foot Ulcers

Introduction: Cytora’s patented and transformative cell platform is based on a novel and unique stem cell population in the oral mucosa, originating from the neural crest, termed human Oral Mucosa Stem Cells (hOMSC). In the oral cavity, they mediate rapid wound healing, promote full tissue regeneration, without scarring. hOMSC200 is an allogeneic off-the-shelf product. Diabetic foot ulcers are a common complication of diabetes and are extremely difficult to treat, leading to significant morbidity.

Methods: The Phase 1/2a trial was a single center, randomized, partially blinded. The study enrolled 21 patients with a mean wound duration of 27 months. Participants received a single administration of either a high or low dose of hOMSC200, or placebo, along with standard care treatments, and were followed up for 18 months. The primary end point was safety. Secondary end points included wound closure.
Results: No related adverse events, and no humoral or cellular immune response elicited by the injected cells. Complete wound closure was higher in the hOMSC200-treated patients in comparison to placebo, with no significant difference between the low and high dose groups. In the intent to treat (ITT) analysis, there was a 53% wound closure in the treatment group versus a 33% in the placebo group. In the per protocol group, there was a 100% success rate, versus a 20% in the placebo group.
Conclusion: hOMSC combine a high therapeutic potency with an excellent safety profile, thus enabling the production of an “off the shelf” stem cell treatment platform for human use.