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- Cynata Therapeutics (CYP) has commenced a clinical trial of its dressing technology (CYP-006TK) in patients with diabetic foot ulcers (DFU)
- CYP-006TK is a novel polymer-coated silicon wound dressing, seeded with Cymerus mesenchymal stem cells to ensure topical application to the wound
- The phase one trial aims to recruit 30 adult patients with DFU and will be conducted at two Adelaide-based hospitals under Professor Robert Fitridge
- Patients will receive study treatment for four weeks and evaluation will continue for 24 weeks with the company expecting the trial to wrap up next year
- Cynata Therapeutics shares have been trading up 5.56 per cent at 47.5 cents
Cynata Therapeutics (CYP) has commenced a clinical trial of its dressing technology (CYP-006TK) in patients with diabetic foot ulcers (DFU).
The phase one trial aims to recruit 30 adult patients with DFU who will be randomly assigned to receive CYP-006TK, a novel polymer-coated silicon wound dressing, seeded with Cymerus mesenchymal stem cells to ensure topical application to the wound.
Up to 34 per cent of those with diabetes will develop a foot ulcer, providing a path for infection which can lead to life-threatening sepsis and/or amputation.
The company has exclusively licensed the dressing technology from innovative biomedical coating manufacturer, TekCyte Limited.
The trial will be conducted at Royal Adelaide Hospital and Adelaide’s Queen Elizabeth Hospital, under Professor Robert Fitridge.
Mr Fitridge is a 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 four weeks and evaluation will continue for a total of 24 weeks with the company expecting trial completion during the 2022 calendar year.
The primary outcome measure in the trial will be safety followed by the secondary outcomes which will include wound healing, pain and quality of life at 12 and 24 weeks.
Cynata chief operating officer, Dr Kilian Kelly, commented.
“Commencing the first human trial is a major milestone in the development of any new product, and we are pleased to have achieved this for our DFU program prior to the end of the year as projected,” he said.
“We look forward to evaluating the effects of this novel treatment on DFU, which are a debilitating and potentially limb or even life-threatening chronic complication of diabetes.”
Cynata Therapeutics shares were up 5.56 per cent to trade at 47.5 cents at 11:47 am AEDT.
