- Cynata Therapeutics (CYP) receives ethics approval to begin a clinical trial of its “Cymerus” mesenchymal stem cell (MSC) product in patients with diabetic foot ulcers
- The study will take place in South Australia led by Professor Robert Fitridge
- It marks the first clinical trial to utilise the wound dressing technology licensed by CYP from TekCyte
- Thirty patients will be recruited for the study, commencing in the second half of the year
- Cynata Therapeutics shares are up by 2.9 per cent to 53 cents apiece at 12:52 pm AEST
Cynata Therapeutics (CYP) has received ethics approval to begin a clinical trial of its “Cymerus” mesenchymal stem cell (MSC) product in patients with diabetic foot ulcers.
The Melbourne-based company has been given the green light by the Central Adelaide Local Health Network Human Research Ethics Committee.
The study will take place at the Royal Adelaide Hospital and The Queen Elizabeth Hospital in South Australia, headed up by Professor Robert Fitridge.
The trial will aim to recruit 30 participants, who will be randomly assigned to receive either CYP’s treatment or standard care treatment.
Notably, it marks the first clinical trial to utilise CYP-006TK, a polymer-coated silicon dressing seeded with Cymerus MSCs, that Cynata has licensed from TekCyte.
The investigational treatment period will span four weeks and each patient will be evaluated for a total of 24 weeks.
Further, while the primary endpoint will be safety, secondary efficacy endpoints will include outcome measures after 12 and 24 weeks, such as percentage ulcer area change; days to complete ulcer healing; days to fifty per cent ulcer healing; percentage change in ulcer volume; and ulcer pain.
Cynata Therapeutics COO Dr Killian Kelly said diabetic foot ulcers could severely impact quality of life and often resulted in hospitalisation, amputation and even death.
“Existing treatment options fail to heal diabetic ulcers in a timely manner, if at all, so new and more effective treatments are urgently needed,” Dr Kelly said.
“We are on target to commence the trial this year and look forward to working with Professor Fitridge and his team on this important study.”
Patient recruitment is expected to commence in the second half of the year, subject to customary approvals and trial start up activities that are underway.
Cynata Therapeutics shares were up by 2.9 per cent to 53 cents apiece at 12:52 pm AEST.