By targeting inflammation, adult allogeneic bone-marrow–derived mesenchymal precursor cells (MPCs) may represent a novel treatment for type 2 diabetes, a new pilot study suggests.
Findings from the multicenter dose-escalating randomized placebo-controlled trial in 61 adults with inadequately controlled type 2 diabetes were published in Diabetes Care by Jay S Skyler, MD, deputy director for clinical research and academic programs at the Diabetes Research Institute, Miami, Florida, and colleagues.
Given as a single intravenous infusion, the cell product, called rexlemestrocel-L (Mesoblast) produced no serious adverse events over the subsequent 12 weeks, including anti-HLA antibodies or sensitization. And the agent was associated with significant reductions in HbA1c compared with placebo infusion.
“This is just a preliminary study. There was no safety issue, which is good, and there may be some beneficial effect….It wasn’t powered for that but showed there might be. We’re pretty excited about that,” Dr Skyler told Medscape Medical News.
He noted that mesenchymal stem cells are “a hot issue at the moment,” because of their anti-inflammatory effects, and that they are being studied for a variety of conditions.
“Type 2 diabetes, because there’s a significant inflammatory component, is an obvious one to look at….There’s evidence that if you reduce inflammation you might get beta cells to work better and you certainly lessen insulin resistance.”
Asked to comment, Allison B Goldfine, MD, head of the section of clinical research at Joslin Diabetes Center, Boston, Massachusetts, said: “This is an extremely interesting proof-of-concept study….Initial human exposures did not reveal major adverse safety signals, but the number of persons exposed was small and each participant received only one dose.”
She added that “mechanistically, the investigators hypothesize that the MPCs change inflammatory mediators of disease but do not show changes in the measured cytokines in these small cohorts.”
Nonetheless, Dr Goldfine called the findings “overall, very preliminary but very exciting.”
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