HomeScience and ResearchScientific ResearchNew Therapy Could Be a Game-changer for high-risk type 1 diabetes

New Therapy Could Be a Game-changer for high-risk type 1 diabetes

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As it may eliminate the need for injecting or dosing insulin externally.

A clinical study suggests that PEC-Direct, an investigational stem cell-based therapy designed to act as a replacement pancreas, has the potential to control blood sugar in patients with high-risk type 1 diabetes.

Multiple patients who received the novel medication showed clinically significant increases in C-peptide, a chemical produced in the pancreas alongside insulin. Because C-peptide and insulin are released at the same time and in roughly similar amounts from the pancreas, testing C-peptide can reveal how much insulin the body is producing.

According to Manasi Sinha Jaiman, from ViaCyte, Inc., “This research represents the first instance in multiple patients of clinically relevant increases in C-peptide, indicative of insulin production, with a stem cell-based therapy delivered in a device.”

Patients with type 1 diabetes gradually lose their ability to control blood sugar levels by producing their own insulin. Patients must check their blood sugar levels frequently using finger sticks, inject several insulin shots, or carry bulky equipment around with them. Insulin injections also carry the risk of reducing blood sugar to dangerously low levels.

The PEC-Direct device is intended to offer a long-term, consistent infusion of insulin to help control blood sugar levels. The device consists of a pouch containing stem-cell derived pancreatic cells that grow into insulin-producing cells after being transplanted into the body, allowing glucose levels to be controlled. Because the device membrane is open, blood vessels can develop into it and contact the cells. Immunosuppressive medications are used to prevent an immunological reaction.

The treatment is intended for individuals with high-risk type 1 diabetes who are at an increased risk of acute complications due to variables such as recurrent severe low blood sugar or difficult-to-control blood sugar variations.

Ten persons with type 1 diabetes who had acquired their diagnosis at least five years prior to the start of the study and were unable to detect low blood sugar levels (called hypoglycemia unawareness) participated in the study. Within six months of implantation of PEC-Direct, one patient had clinically meaningful levels of stimulated C-peptide and commensurate improvements in blood glucose control. Since then, several patients have reported improved C-peptide levels, as well as reductions in HbA1C (a blood test that assesses average blood sugar levels over the previous three months) by as much as 1.5 percent and reductions in the quantity of insulin they need to inject by as much as 70 percent.

The findings of the study show that “stem cell-based replacement therapy has the potential to provide blood glucose control and could one day eliminate the need for injecting or dosing insulin externally,” Jaiman added.

“The study provides further proof-of-concept that continued optimization of PEC-Direct has promise as a functional cure for type 1 diabetes.”

Image Credit: Getty

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