Stem cell therapies are often associated with dodgy back-street clinics that do no more than remove your stem cells from one part of your body and inject them back into another. These treatments are autologous, meaning the stems cells are taken from the donor, cultured, and returned to the same donor.
Anecdotal evidence does exist to show this can be effective in improving a patient’s symptoms. Mel Gibson is one high-profile patient that has backed the treatment. However, there is no hard-clinical trial data to support this use.
Furthermore, this type of treatment is not scalable and big pharma companies are unable to mass-produce the cells as any consistent form of medication. In this instance, it is a once-off procedure.
At this point in time, we don’t have an off-the-shelf stem therapy available – but it’s not far away
Treatment using stem cells from another donor is an allogenic stem cell donation. Many companies are investigating treatments using this form of a donation, including Cynata Therapeutics (ASX:CYP).
Cynata uses mesenchymal stem cells, also known as MSCs – which it manufacturers using its proprietary platform called Cymerus.
Cymerus was developed at the University of Madison, Wisconsin, and is a ground-breaking platform in the field of stem cell research and development.
MSCs are multipotent stromal cells that can differentiate into a variety of cells. The challenge being experienced by many companies using these cells is the ability to secure enough of the cell type from one donor.
Often, they are taken from bone marrow, fat tissue and other tissues. And once taken, the cells cannot be expanded indefinitely. After a certain number of times, they lose their potency.
This also causes issues for the regulators that will only approve a standardised therapy for sale. Each patient must receive the same type of biological material, meaning that every batch must be manufactured according to the same starting material. And if that starting material runs out, or changes, the drug is no longer approved.
Case in point was last year, when four stem cell companies in Korea were raided by the Korean authorities after being suspected of switching the donors for their starting materials, and thereby altering the therapy that received the approvals from the governing body.
Currently there are no approved drugs that use this method in Australia, due to the challenges associated with scaling the production and mass manufacturing a consistent, quality drug.
Cynata could well be one of, if not, the first to do this.
Cynata’s Cymerus platform has the ability to mass manufacture a consistent batch of MSCs, creating a true off-the-shelf product
The platform requires only one donor and one procedure to create an infinite amount of the product. A little-known marvel called induced pluripotent stem cells (iPSCs) is used instead of the MSCs as a starting material.
iPSCs are adult stem cells that are reprogrammed to mimic an embryonic stem cell, yet are not embryonic, and do not come with any of the associated controversy.
The embryonic likeness gives them the ability to develop into any other cell type. iPSCs are not a new discovery, having been discovered more than 10 years ago they have become instrumental in biological research.
By harnessing iPSCs and its proprietary Cymerus technology, Cynata has developed its first MSC product that has completed a successful phase I clinical trial (in Australia and the UK) and is now progressing to a phase II in the treatment of graft-versus-host-disease – a fatal disease often arising in transplant patients.
There is no doubt that stem cell therapies can work. The challenge is making them viable for mass production and developing a safe therapeutic product that can be regulated.
This content is produced by Star Investing in commercial partnership with Cynata Therapeutics. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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