Allogeneic bone-marrow–derived mesenchymal stem cells may prove to be an effective treatment for type 2 diabetes, a new pilot study by Diabetes Research Institute, Miami, Florida, suggests. The results of the study have been recently published online in the journal Diabetes Care.
The randomized placebo-controlled trial involved 61 adults from 18 US centers. All these patients had inadequately controlled type 2 diabetes that showed in hemoglobin A1c levels of 7.0% or higher despite intake of medications which should lower this indicator (hemoglobin A1c provides an average of the patient's blood sugar control over the past 2 to 3 months, the levels between 4% and 5.6% being the normal range and over 6.5% indicating diabetes).
The study was dose-escalating – the patients were randomized to receive single intravenous infusions of cell products containing three different—increasing—cell doses (n = 15 for each dose), or placebo infusions (n = 16).
Given as a single intravenous infusion, the stem cell product produced no serious adverse effects over the subsequent 12 weeks in any of the patients. The cells taken for infusions were allogeneic, in other words, taken from a donor and not from patients themselves, and the researchers were interested if this could cause histocompatibility problems. However, no anti-HLA antibodies or sensitization were observed in any of the patients. At the same time, treatment caused significant reductions in hemoglobin A1c levels compared with a placebo group.
Though the study was a preliminary one and not powered enough to prove beneficial effects of the stem cell treatment, the researchers are very excited. As in type 2 diabetes there is a significant inflammatory component, the researchers believe they can make beta-cells of diabetic patients working better and reduce insulin resistance due to anti-inflammatory stem cell properties.