In a nutshell
This study examined the safety and effectiveness of a combined stem cell therapy method in individuals with established type 1 diabetes. The study concluded that this therapy was save and led to improvements in average blood glucose levels and insulin doses required.
Some background
Type 1 diabetes (T1D) is an autoimmune disease. This means that the body attacks itself and destroys part of an organ called the pancreas. The pancreas is the organ responsible for the production of insulin, the hormone needed to break down the glucose taken in from food. Therefore, current treatment methods involve replacing the insulin that the body can no longer produce with insulin injections.
Recently, stem cells taken from bone marrow (fatty substance in the center of bones that produces red blood cells) and umbilical cords (cord that attaches a fetus to the placenta inside the uterus) have been investigated as a new treatment. Stem cells have the potential to grow and develop into any cell type or tissue in the body, including cells of the pancreas. The introduction of new pancreatic cells could replace those that are no longer able to produce insulin.
Methods & findings
This study evaluated the safety and effectiveness of stem cell therapy (SCT) for treating T1D. This study included 21 patients treated with SCT and another 21 patients treated with standard care (insulin treatment and self-monitoring of blood sugar levels). SCT involved a single procedure, where the stem cells were transferred to the patient’s pancreas. The patients were then monitored for 1 year at 3-month intervals. Beta cell function (cells that produce insulin), HbA1c levels (average blood glucose levels over 3 months), fasting blood glucose (levels of glucose in the blood after several hours without food) and daily insulin requirements were measured.
Beta cell function increased significantly in the SCT group, and decreased in the standard therapy group. HbA1c decreased 12.6% in the SCT group and increased 1.2% in the standard therapy group. Fasting blood glucose decreased 24.4% in the SCT group and 4.3% in the standard care group. Significant decreases in daily insulin requirements were observed in the SCT group (29.9%) was unchanged in the control group.
In the SCT group, stomach pain and bleeding were each reported in 1 patient, but these cases were resolved without problems. The amount of infections reported was similar between the two groups. No severe safety problems were observed during the follow-up period.
The bottom line
This study concluded that this form of stem cell therapy (a combination of stem cells from bone marrow and umbilical cord) is safe and is associated with small improvements in beta cell function, HbA1c levels, fasting blood glucose and daily insulin requirements.
The fine print
The limitations of this study included the low patient participant number (only 42 in total) and there was also a short duration of follow-up. Further studies are needed to determine whether these results can be generalized to a larger population.
Published By :
Diabetes Care
Date :
Dec 01, 2015