Rexlemestrocel-L (mesoblast) can reduce A1c after a single intravenous infusion…
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Researchers at Diabetes Research Institute, Miami, Florida recently discovered mesenchymal stem cells are able to reduce body inflammation, thus allowing beta cells to function better and lessen insulin resistance. According to Dr. Jay S Skyler, this discovery of mesenchymal stem cells is “a hot issue at the moment and due to their anti-inflammatory effect, they are subjects of interest in a variety of conditions.”
Dr. Skyler and his team conducted a randomized, placebo-controlled pilot study in 61 subjects with type 2 diabetes for an average of 6 years. The mean A1c levels of all participants at baseline was 8.3 and they were taking metformin or in combination with another diabetes medication (except for a thiazolidinedione). The participants were randomized to receive a single intravenous infusion of MPCs (rexlemestrocel-L; Mesoblast Inc.) 0.3 × 106/kg (n = 15), 1.0 × 106/kg (n = 15), or 2.0 × 106/kg (n = 15) or placebo (n = 16) and they were being followed for a 12-week period.
According to the study, no side effects were reported during the infusion or in the following 6 hours. During the subsequent 12 weeks, one patient in the low dose treatment group experienced severe abdominal pain and two patients had mild-moderated upper respiratory infection. Furthermore, “No subjects developed donor-specific anti-HLA antibodies or became sensitized.” When compared with the placebo, reduction in A1c was seen after week 1 with a single IV infusion of rexlemestrocel-L. The greatest difference between rexlemestrocel-L and placebo (0.4mmol/mol) was observed at week 8 (P<0.05) with no differences in fasting blood glucose levels across treatment groups.
The results from the study support the effectiveness of mesenchymal stem cells in diabetes treatment, but larger clinical trials are needed to consolidate the evidence. According to Dr. Skyler, “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.”
- Mesenchymal stem cells reduce body’s inflammation, enhance beta cells function and lessen insulin resistance.
- A1c reduction was observed at week 1 after a single IV infusion of rexlemestrocel-L. The greatest reduction was observed at week 8.
- No major side effects were reported during the experiment.
Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. “Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose Escalation Safety and Tolerability Pilot Study.” Diabetes Care. 2015 Jul 7. pii: dc142830.