#Israel #Diabetic Foot Ulcers #Yokneam #Cytora #Stem Cell Treatment

Cytora Reports Triumph in Phase 1/2a Clinical Trial on Stem Cell Cure for Diabetic Foot Ulcers

Cytora, an emerging biopharmaceutical company, has recently reported groundbreaking results from a Phase 1/2a clinical trial for their innovative treatment targeting diabetic foot ulcers (DFUs). Based in Yokneam, Israel, Cytora specializes in developing pioneering therapies using human Oral Mucosa Stem Cells (hOMSCs). The results from this trial spotlight the potential of hOMSC200, their leading allogeneic cell therapy product, to transform the standard treatment protocols for DFUs.

In a significant turn of events, the trial showcased that not only is hOMSC200 safe for use—showing no adverse immune responses—but it also proved to be considerably more effective than conventional treatment methods. The promising outcomes of this trial could pave the way for new treatment options for the millions affected by diabetes, who frequently suffer from prolonged and complicated wound healing processes.

Prof. Sandu Pitaru, the Co-Founder and Chief Technology Officer at Cytora, detailed the innovative technology powering hOMSC200. This product utilizes a unique stem cell population derived from the human oral mucosa, a discovery that could potentially alter the landscape of stem cell therapy. Remarkably, this population is rooted in primordial tissues that are vital to early embryonic brain development, retaining their effectiveness into adulthood. This unique nature of the cells grants them capabilities to treat multifaceted chronic diseases, including chronic wounds and various neurodegenerative conditions.

According to Yona Geffen, PhD, the CEO of Cytora, the implications of these trial results extend beyond mere numbers. “Diabetic foot ulcers represent a significant clinical challenge that frequently leads to heightened morbidity. Our study, which enrolled 21 participants—with wounds averaging over two years—demonstrates not only the safety of hOMSC200 but also its superior effectiveness, which could revolutionize the treatment landscape for patients who have exhausted standard treatment options.”

The Phase 1/2a trial was designed as a single-center, randomized, and partially blinded evaluation, with participants divided into two hOMSC200 dosing categories alongside a placebo group. Throughout the 18-month follow-up, patients received either a one-time low or high dose of hOMSC200 or a placebo, all while adhering to standard wound care practices. This structure allowed for a thorough investigation into the treatment's safety and efficacy.

The results were compelling; there were no recorded side effects, nor any immune response against the administered stem cells. On analyzing overall wound closure rates, hOMSC200 recipients exhibited a significant improvement compared to those in the placebo group, with a noteworthy complete wound closure rate of 53% against a 33% closure rate for the placebo. In the per-protocol group adhering strictly to the study guidelines, every patient achieved complete wound closure.

Cytora's research not only highlights the progress of hOMSCs and their favorable therapeutic potential but also emphasizes the alarming reality of diabetic foot ulcers. Roughly 19% to 34% of diabetics will have to contend with DFUs during their lives. The severe consequences of these ulcers—which range from infections to amputations—underscore the critical need for effective treatments. While various approaches exist, including advanced therapies, the healing rate remains unsatisfactory, leaving a substantial gap in patient care.

With approximately 1.2 million new DFU cases annually in the U.S. and a treatment cost averaging around $20,000, Cytora is confronting an enormous medical need. The clinical findings from this latest trial bolster their position as they prepare to seek an Investigational New Drug (IND) application in the latter half of 2025, aiming for a large-scale Phase 2 trial in 2026.

Cytora's commitment to addressing chronic wounds and degenerative diseases through its technology reflects the insightful research stemming from Prof. Pitaru’s work with hOMSCs. With their potent safety profile and the capacity for mass propagation without losing stem cell properties, Cytora is on the brink of bringing a revolutionary approach to treat chronic wounds into the hands of practitioners and affected individuals worldwide.

As we look forward to the next stages in clinical trials and continued advancements from Cytora, hope brews for patients grappling with the daily struggles resulting from diabetic complications. The fusion of innovative science and rigorous clinical validation may well redefine the management of diabetic foot ulcers, illustrating a bright future for regenerative medicine.

For more information about Cytora and their promising technologies, visit Cytora Stem.