Due to reduced blood flow, patients with diabetes are at risk of developing non-healing or infected wounds. These wounds (also known as diabetic ulcers) most commonly occur on the feet, and affect up to 34% of patients with diabetes during their lifetime . Diabetic wounds must be treated immediately to avoid infection that can lead to life threatening sepsis and/or amputation.
Cynata’s Cymerus™ mesenchymal stem cells (MSCs) were used in an independent study conducted by the Cooperative Research Centre for Cell Therapy Manufacturing (CTM CRC) in a preclinical model of diabetic wounds.
CTM CRC evaluated cells from five different sources: Cymerus MSCs, bone marrow-derived MSCs supplied by a commercial manufacturer, and MSCs derived from dental pulp, bone chips and gingival fibroblasts (cells found in the gums).
The primary outcome measure was the extent of re-epithelialisation (skin restoration) of the wound surface after three days, which is representative of the speed of wound healing.
These results suggest that the most effective cell types for this application are Cymerus MSCs or MSCs derived from gingival fibroblasts or bone chips. However, the gingival fibroblast- and bone chip derived MSCs were produced in an academic laboratory under non-GMP conditions, and there are major challenges associated with producing clinical-grade cells from those sources at commercial scale. Conversely, Cynata’s Cymerus technology platform provides a readily available and effectively limitless source of consistent, clinical-grade MSCs.
Building on the very encouraging pre-clinical data Cynata commenced in December 2021 a randomised controlled clinical trial in 30 patients with diabetic foot ulcers. This is the first clinical trial to utilise CYP-006TK, a novel polymer-coated silicon dressing (seeded with Cymerus MSCs) to facilitate topical application to the wound. Cynata has exclusively licensed the dressing technology from leading manufacturer of innovative biomedical coatings, TekCyte Limited.
The trial is taking place at Royal Adelaide Hospital and The Queen Elizabeth Hospital, Adelaide, under the leadership of Professor Robert Fitridge, who is Professor of Vascular Surgery at the University of Adelaide, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network. Patients will receive study treatment for a period of 4 weeks and evaluation will continue for a total of 24 weeks. The primary outcome measure in the trial will be safety, while secondary outcome measures will include wound healing, pain and quality of life at 12 and 24 weeks after treatment initiation.
 Diabetes Australia