Clinical-stage stem cell and regenerative medicine company, Cynata Therapeutics has launched a ‘Phase I’ clinical trial on its Cymerus mesenchymal stem cell product used to treat diabetic foot ulcers, or “DFUs”, in humans. The company will now look to enrol 30 patients for the trial that will evaluate safety, wound healing, pain and quality of life of the patients after treatment initiation.
Cynata recently entered an exclusive global licence agreement with leading developer and manufacturer of thin-film polymer coatings, TekCyte. In the upcoming trial, a type of polymer-coated silicon dressing developed by TekCyte, named ‘CYP-006TK’ will be used to apply Cymerus mesenchymal stem cells, “or MSCs” to foot ulcers.
According to Cynata, the clinical trial will be the first to employ the CYP-006TK dressing seeded with Cymerus MSCs.
Cynata now plans to recruit 30 patients who will randomly receive CYP-006TK or other standard care treatments in the trial. The investigation treatment period will run for four weeks, with each patient to be evaluated over a 24 week period.
The primary outcome measured in the trial will be safety, with secondary measures to include wound healing, pain and quality of life in patients who will be assessed at 12 and 24 weeks after treatment initiation.
The trial will be conducted at the Royal Adelaide Hospital and the Queen Elizabeth Hospital in Adelaide and is expected to conclude in the 2022 calendar year.
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. 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.
According to Cynata, diabetes is the world’s fastest growing chronic disease that could affect about 630 million adults by 2045.
Nearly 34 per cent of diabetics are estimated to develop DFUs that could potentially lead to infection and in turn life-threatening sepsis and even amputations, the company says.
A recent report conducted by global research organisation Transparency Market Research projected the global DFU treatment market could be worth a remarkable US$9.6 billion by 2027.
Cynata says DFUs represent a significant unmet medical need. Its upcoming clinical trial on treating the debilitating disease could send the Perth-based company a step closer to tapping into a lucrative global market.
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