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While you may see a couple of news articles each year with researchers claiming they’ve found a successful cure for a type 1 diabetes new treatment, the majority don’t make it past animal trials and are never heard from again because they don’t pass the early stages of safety.
We hear all the time from our healthcare team and experts that a cure is just around the corner. This is because research is curing diabetes in mice.
Researchers have made huge advances but we’re still nowhere close.
Out of all the research into finding a cure, it comes down to one, maybe two, that have the potential to make it through each critical trial phase.
Hopefully, one of these will make it, and bring a cure to people with type 1 diabetes
Viacyte’s implantable capsule device is closest to paving the way to a successful cure.
A capsule full of stem cells is implanted within the abdominal cavity, the precursor cells then mature into fully functioning endocrine cells that produce insulin.
However, the critical detail that makes or breaks Viacyte’s success is the body’s ability to “vascularize” the product.
“Vascularizing means that blood is flowing through it, allowing the pancreatic progenitor cells to mature into insulin-producing islet cells.
The procedure itself is intensive and would require a few weeks of recovery due to surgically cutting through the abdomen to place the capsule.
“And then, it takes several months for the product to get vascularized in your system, mature into islet cells and start producing useful insulin.”
Because the capsule isn’t connected in any way to the existing pancreas, and it’s safe from the patient’s self-destructive immune system, the beta cells can thrive and produce insulin to successfully manage blood sugar levels.
However, do keep in mind, it’s expected that patients would need to undergo the procedure perhaps every year in order to implant more progenitor cells; this is what ViaCyte is testing in the initial cohort of the ongoing Phase I/II Clinical trial with the smaller, sentinel units.
“They’ve just completed Cohort 1 of their phase I/II trial, but please bear in mind that, even though they’re making good progress, they still have a long way to go. It has taken ViaCyte 6 years to get to the stage they are now at
Let’s take a closer look at the phases they must achieve over the next decade:
Phase I: Safety & Tolerability
Cohort 1 of this Phase I/II study was focused on the capsule’s ability to become vascularized within the human body. This phase was not about if it could reduce blood sugars, but simply that the body was able to accept and make use of the capsule by allowing blood to flow through it and using the cells that were been produced in the capsule.
The cells only produce insulin after entering the patient’s own bloodstream.
Viacyte accomplished this phase in 2018 with a small trial of 4 patients.
Phase II: Efficacy & Side-Effects
As Viacyte begins Cohort 2 of Phase I/II study, this is where they find out if the vascularized capsule will produce insulin and control a patient’s blood sugar levels.
They are recruiting 55 patients, who will be vascularized, so the test can prove efficacy, it may take 2 years to compile that data and progress to Phase III
Phase III could potentially begin around 2022 if all goes well in phase I/II.
Phase III: Efficacy, Superiority & Monitoring of Adverse Reactions
Phase III in clinical trails is when the treatment method or drug is tested on a wider population of patients, for a longer period of time,
They would need between 300-3,000 patients, and would likely need to be global. Going global is crucial because patients from one part of the world have different genotypes and phenotypes and this could affect the results of the treatment.
This phase would last for 1 to 4 years to further determine safety, efficacy, and long-term stability in multiple sub-populations.
Phase IV: Submit for FDA approval
This is the phase we are all hoping for — when the treatment has proven to be widely safe and effective and becomes available to the rest of the population of type 1 diabetics
If all goes well with the trials we could see the Encaptra delivery system commercially available by the year 2030.