Following receiving favourable advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in March, stem cell and regenerative medicines company, Cynata Therapeutics (ASX: CYP), has taken further steps to advance its phase two clinical trial in Critical Limb Ischaemia (CLI).
Cynata have engaged a leading clinical research organisation to progress the trial that it anticipates conducting at centres in Australia and the UK.
The company says that it is now at the final draft stages of the clinical trial protocol.
The protocol has “been reviewed and commented on by clinical key opinion leaders with expertise in CLI.”
Preparation, preparation, preparation
Before progressing to trial, the research organisation will be responsible for finalising the clinical trial protocol and preparation of all documentation to support the trial.
Much of the work that goes into a clinical trial occurs before the trial has even begun.
Cynata and the research organisation must have in place consent forms, study reference materials, project plans and trial sites must be evaluated and selected.
The paperwork involved in a clinical trial is momentous. Once the study protocol is established, the appropriate paperwork is to be submitted for regulatory and ethics approvals.
With the paperwork in place, the trial sites selected in the trial must be briefed and trained.
Recruitment expected to begin in fourth quarter
The phase two trial will see Cynata’s mesenchymal stem cell (MSC) product CYP-002 used to treat patients with CLI.
CLI is an advanced stage of peripheral artery disease (PAD) that is a narrowing of arteries in the limbs.
The narrowing of arteries impairs blood flow which causes pain and tissue damage – with the end result often amputation of the affected limb.
Preclinical results showed that administering CYP’s MSCs resulted in the return of blood flow to the affected limb.
Dr Kilian Kelly, Cynata’s Vice President, Product Development said that “there is a very high level of enthusiasm among the clinical community about this trial, which we hope will help to address what is currently an extremely serious and difficult to treat condition.”
Cynata expects to commence recruitment by the fourth quarter of this calendar year and is the company’s third phase two clinical trial in train.
In a proposed clinical trial with the University of Sydney, Cynata’s stem cells will be investigated as a potential treatment for osteoarthritis; this is now in the planning phases and the Company’s second clinical trial in GvHD is also expected to begin later this year – in collaboration with Fujifilm.
This content is produced by Star Investing in commercial partnership with Cynata Therapeutics. This content does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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