According to Manasi Sinha Jaiman, MD, MPH, Medical Director, “This study represents the first case in many patients of a clinically relevant increase in C-peptide, indicative of insulin production. , with stem cell-based therapy delivered in one device. of ViaCyte, Inc., of San Diego, California, which manufactures PEC-Direct.
Type 1 diabetics eventually lose the ability to produce insulin to control blood sugar. Patients must regularly check those levels with finger sticks, multiple insulin injections, or carry bulky devices. Insulin injections also carry the risk of inadvertently lowering blood sugar to dangerous levels.
The PEC-Direct device is designed to provide a steady, long-term insulin supply to regulate blood glucose levels. The device consists of a vesicle containing stem cell-derived pancreatic cells, which mature into insulin-producing cells after being implanted in the body to regulate glucose levels.
Stem cells for diabetes
The open device membrane allows blood vessels that grow into the device to come into contact with the cells. To suppress the immune response, patients take immunosuppressive drugs.
A treatment for high-risk type 1 diabetes patients who may be particularly susceptible to acute complications from severe recurrent low blood sugar or frequent blood sugar fluctuations. frequent and extremely difficult to control.
The study included ten adults with type 1 diabetes who received their diagnosis at least 5 years before the study began and could not tell when their blood sugar was too low (called hypoglycemia unrecognized).
Preliminary data from one patient showed the clinical relevance of stimulated C-peptide and corresponding improvements in glycemic control within six months of PEC-Direct implantation.
Since then, increased C-peptide levels have been seen in many patients, along with a decrease in HbA1C (a blood test that measures average blood sugar levels over the past three months) by 1.5% and a decrease in insulin levels. patients need to use up to 70%.
“The study provides further proof of concept that further optimization of PEC-Direct holds promise as a functional cure for type 1 diabetes.”