June 20, 2022 — Clinical trials of new freeze treatments for stroke should be delayed until the technology used in the tests improves, according to research conducted at the University of Strathclyde.
The researchers say failure to do so could have ‘devastating’ effects on the outlook for treatments used for strokes and other conditions.
Stroke currently lacks treatments, in part because, so far, stem cell therapies cannot be used for chronic strokes.
The gels have the potential to be an effective stroke treatment, due to their ability to fill brain cavities created by strokes and their ability to interact with glial scars, a type of scar that forms in the cavity area and seals it. from the rest of the brain.
The gels could also be effective in delivering the drug and stem cell payload, thanks to unique properties that can be tailored to the requirements of a specific stroke site.
But no clinical trials have so far been successfully commissioned to explore the potential of regenerative gels for the treatment of chronic stroke. This was partly because preclinical laboratory studies did not consider the full range of ages and health conditions of stroke patients.
Researchers reviewed more than 90 research papers from the past five years, focusing on five types of gels with potential for use in stroke, and found this to be a ‘bottleneck’ in development new therapies. The authors recommend that studies come to a better understanding of how gels interact with human stroke tissue, as well as the effects of increasing gel volume on the size of stroke patient cavities. .
The study was published in the journal Trends in biotechnology.
Dr Hilary Carswell, a reader at the Strathclyde Institute of Pharmacy and Biomedical Sciences, is the lead author of the study. She said: “Stroke is a huge unmet clinical need and there is an urgent need to move to new treatments. There has been success in some preclinical trials of gels but our research has identified knowledge gaps that need to be filled before clinical trials can proceed.
“Stroke often has many co-morbidities, such as hypertension, diabetes and obesity, but the gels offered have not yet been tested against these conditions. A stroke cavity can be as large as 50 cm3 preclinical research must therefore be extended to the size of the human brain.
“Gels have a lot advantages but we need to get these things worked out before they can move into clinical trials and be translated into treatments.
The study also involved King Abdulaziz University in Jeddah, Saudi Arabia.
The authors say: “We urge a postponement of the commissioning of clinical trials to minimize the risk of poor performance in the early stages of trials. While this is frustrating given the overall slow progress in developing stroke therapies, the importance of successful gel-based clinical trials cannot be underestimated. If unsuccessful, premature gel-based clinical trials could have devastating effects on the future of these technologies, both in stroke and in broader regenerative applications.
“Therefore, in order to maximize the future of regenerative gels and realize their full potential, a careful approach is needed to ensure their success when they finally enter the clinic.”
Stroke is one of the leading causes of death and disability worldwide. In about 85% of cases, stroke is caused by an ischemic event due to a blockage of blood supply to the brain.
For more information: www.strath.ac.uk