People suffering from Type 1 diabetes can now rejoice as clinical trials are underway for the new FDA-approved PEC-DirectTM implant that has the potential to functionally "cure" insulin-dependence once and for all.
The device, a stem cell-based product, was developed by ViaCyte, a private company known for its work on regenerative medicine. And is designed to eliminate the need for daily insulin injections by producing insulin within the body.
Type 1 Diabetes: Less Famous But More Dangerous
Only 10% people suffering from diabetes have the Type 1 version of it, which unlike Type 2 is an autoimmune disease that causes the body's immune system to destroy its own pancreatic β-cells (cells that are responsible for producing insulin).
This leads to dangerous episodes of hypoglycemia (low blood sugar) that can even cause coma and death.
Furthermore, unlike Type 2 diabetes, which can be reversed through a strict diet and exercising, Type 1 diabetes is a disease that is still considered incurable.
But that might not be the case for much longer.
PEC-Direct Sentinels: The Potential Cure
Before attempting to "cure" insulin-dependence, ViaCyte first studied the effects of the PEC-Direct within the human body through a small clinical trial in 19 diabetic patients.
These patients were not given the standard PEC-Direct, but were instead implanted with a smaller version of it with limited number of PEC-01 cells.
The objective was to test the growth of the stem cells and evaluate the insulin produced after they transformed into pancreatic islets.
Once that was successful, the team then mapped out the trial that is going on currently in 2 patients.
A trial to find out if PEC-Direct can completely replace insulin injections in high risk Type 1 diabetic patients.
A Reliable Replacement For Pancreatic Transplantations
Image source: Viacyte
The PEC-Direct is a small implant that contains proprietary stem cells called PEC-01 within an impermeable housing with pores all over to allow blood vessels to directly nourish the stem cells within
Once implanted, the PEC-01 cells grow and transform into pancreatic β-cells within a few months, after which they start producing insulin to supplement the body's lack of it.
Maybe that's why the device is also called "Sentinel" as it is meant to protect the patient from severe hypoglycemic emergencies.
In fact, if its clinical trial is successful, it even has the potential to overcome all the challenges faced by the current treatment options for Type 1 diabetes.
Challenges Of Organ Transplantation And How PEC-Direct Can Replace The Need For It
The only other treatment option for Type 1 diabetic patients (other than injecting insulin daily) is pancreatic islet cell transplantation from suitable donors.
But this method is fraught with challenges like limited supply of donor organs and unreliability of prepared islet cell samples.
PEC-Direct is the solution to these problems.
ViaCyte has unlimited supply of proprietary stem cells to produce its sentinels. And they also have quality controlled methods to produce samples consistently and reliably every single time.
Furthermore, the PEC-Direct can be easily removed, if the patients want it, which is not an option after organ transplantation.
High Risk Type 1 Diabetes And The Need For This Device
PEC-Direct is specifically created for 3 types of patients:-
1. Patients who have a high frequency of severe hypoglycemic emergencies.
2. Those who fail to respond to conventional treatments (also known as "Brittle Diabetics").
3. Patients with hypoglycemic unawareness in whom the adrenaline feedback loop fails to trigger even when the body has dangerously low levels of blood sugar.
The Only Shortcoming
While PEC-Direct is a marvellous product and has the potential to "cure" Type 1 diabetes, it is still an implant that requires immune-suppressants to prevent severe immune cell reactions.
To combat this, ViaCyte is currently developing a similar product called PEC-Encap, which unlike the PEC-Direct is housed in a semi-permeable case that will not trigger any immune response.
And although clinical trials for this product will take a while, if successful, it has the potential to be a cure for all diabetic patients, irrespective of risk type.
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Image source pancreas: Blausen Medical