Stem cell biotechnology company Cynata Therapeutics has started clinical trials with an initial cohort of patients in Adelaide of its patented product, aimed at treating diabetic foot ulcers.
The innovative polymer-coated silicon wound dressing CYP-006TK contains the company’s proprietary Cymerus mesenchymal stem cells, or ‘MSCs’, for topical application to wounds.
The company noted Covid-19 challenges had impacted the progress of the trials but said they had now been addressed and the trial was now expected to be completed by the end of the year.
Initial patients have enrolled in the four-week treatment period with the study of a proposed 30 adult patient-groups expected to be concluded in six months.
The wound dressing technology is licenced from leading manufacturer of innovative biomedical coatings, TekCyte Limited, and seeded with Cynata’s proprietary therapeutic stem cell platform technology Cymerus.
The company said Cymerus resolves issues facing other cell therapy production methods by using induced pluripotent stem cells and a precursor cell known as mesenchymoangioblast to achieve the economic manufacture of cell therapy products, including MSCs, at a commercial scale without the limitation of multiple donors.
Cymerus has a unique ability to yield highly consistent MSCs at scale from a single donation.
We are pleased with enrolment of subjects following the commencement of the trial in late December. COVID-19-related changes to patient management at the study sites, initiated shortly after the trial opened, posed a significant number of unforeseen challenges which had a serious impact on enrolment rates. Fortunately, these challenges have now been addressed.
Dr Airey says the company has also implemented a number of strategies, such as widening recruitment criteria, that is intended to accelerate the recruitment of trial patients.
According to management Cynata continues to work closely with Professor Fitridge and the Central Adelaide Local Health Network to ensure the trial is completed later this year.
Cynata has a number of cell therapy developments in its platform pipeline.
Its lead product CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data in treating steroid-resistant acute graft-versus-host disease in a Phase 1 trial. It is currently planning a Phase 2 clinical trial.
It is also in Phase 3 clinical trials to treat osteoarthritis, along with treatments for respiratory failure.
Additionally, Cynata says it has demonstrated the benefits of its Cymerus technology in preclinical models of a number of diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome and cytokine release syndrome.
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