In a significant development for diabetic foot ulcer treatments, Cynata Therapeutics Limited (ASX: CYP), a leading clinical-stage biotechnology company, has announced the completion of patient enrollment in its Phase 1 clinical trial. This trial evaluates the efficacy of CYP-006TK, a novel cell therapeutic developed by Cynata, for treating diabetic foot ulcers (DFU), a common yet severe complication of diabetes.

Cynata Therapeutics Limited, known for its specialization in cell therapeutics, has achieved a major milestone by completing patient enrollment in its Phase 1 clinical trial of CYP-006TK, targeting the treatment of diabetic foot ulcers (DFU). This trial is a pivotal step toward addressing the critical need for effective treatments for DFU, which pose a significant risk of infection and, in severe cases, may necessitate amputation.

CYP-006TK, Cynata’s innovative product candidate, is a mesenchymal stem (or stromal) cell (MSC) topical wound dressing, derived from Cymerus induced pluripotent stem cell (iPSC) technology. It utilizes MSCs seeded onto a novel silicon dressing, aimed at promoting wound healing in patients suffering from DFU, a condition characterized by non-healing wounds on the feet or lower limbs due to reduced blood flow, common among diabetes patients.

The trial has randomized a total of 30 patients with DFU on a 1:1 basis to receive either the CYP-006TK treatment for four weeks, followed by standard care, or to receive standard care throughout the study. With a follow-up period of 24 weeks post-treatment initiation, the final patient visit is anticipated around September 2024.

Dr. Jolanta Airey, Chief Medical Officer at Cynata, expressed her gratitude towards the participants and staff involved in reaching this enrollment milestone. Preliminary data from the first 16 patients have shown promising results, with a median reduction in wound surface area of 87.6% in the CYP-006TK group compared to 51.1% in the control group, highlighting the potential efficacy of CYP-006TK in wound healing.

Cynata Therapeutics Limited is at the forefront of stem cell and regenerative medicine, with its proprietary Cymerus technology offering a scalable and economical solution for the commercial production of therapeutic stem cells. Besides the ongoing trials for DFU, Cynata’s product pipeline includes CYP-001 for the treatment of steroid-resistant acute graft-versus-host disease (GvHD), with positive Phase 1 trial results, and ongoing trials in osteoarthritis and renal transplant.

This development is a testament to Cynata’s commitment to advancing stem cell therapy and regenerative medicine, offering hope for effective treatments for debilitating conditions like diabetic foot ulcers.

  Cell Therapeutics, Cymerus iPSC-derived MSCs, Cynata Therapeutics Limited, CYP-006TK, Diabetic Foot Ulcers Treatment, Mesenchymal Stem Cells, Phase 1 Clinical Trial, Regenerative Medicine, Stem Cell Technology