Diabetes Care recently published online before print full results from a phase 2 trial of Mesoblast’s mesenchymal precursor cell (MPC) treatment for type 2 diabetes aimed at reducing inflammation. Topline results were released at the end of 2013. The multicenter 12-week, single-blind, dose escalation trial randomized 61 type 2 diabetes patients (mean A1c of 8.3% and diabetes duration of 10 years) to receive a single intravenous infusion of 0.3, 1.0, or 2.0 million MPCs/kg or placebo. After 12 weeks, the MPC treatment produced modest, dose-dependent A1c reductions compared to placebo (0.0%, -0.1%, and -0.3% respectively for the 0.3, 1.0, and 2.0 million MPCs/kg doses). The greatest difference in A1c was seen in the highest dose group at week eight with a 0.4% reduction vs. placebo (P<0.05). At 12 weeks, five (33.3%) subjects in the highest dose group had achieved the <7% A1c target compared to none in the placebo group (P<0.05). As is commonly seen, the treatment seemed to demonstrate greater efficacy in patients with starting A1c ≥8% – a 0.4% reduction in the highest dose group compared to a 0.2% reduction in patients with a starting A1c <8%. There was no observed difference in fasting glucose levels, suggesting this treatment may be targeting postprandial effects. Crucially, the study saw no serious adverse events, serious hypoglycemia, or discontinuations over the 12-week trial period, meeting its primary endpoint. In addition, no immune responses against MPC donor antigens were identified in any subject. We are glad to see these reassuring safety results and look forward to seeing efficacy results from more robust trials in the future. Stem cell treatments are a hot topic in diabetes treatment right now, though most therapies in the pipeline are focused on type 1 diabetes (see Melton group and ViaCyte). Mesoblast is also currently in phase 2 trials investigating MPCs as a diabetic nephropathy treatment.
Testimonials Read More
Arlene and her AHPR team are simply the best in the business, the “A Team.” Arlene was recommended to me by a physician friend of mine for whom she had coordinated national media spots on top shows like the Today Show and Nightline. Arlene and I have only been working together for a few months, yet she has already arranged appearances for me with Forbes and Wall Street Journal, and I am on track to be on The Doctors as well…such an amazing accomplishment! Arlene and her team are dedicated, hard-working, creative, successful, and to top it off, they are so fun to work with. Arlene truly takes her clients’ interests to heart, and she rejoices and takes pride in their ultimate success! I highly recommend Arlene and her “A Team!”
Ming Wang MD; phD
CEO of Aier-USA, director of Wang Vision Institute, Nashville, TN, USA
Arlene Howard PR is excellent at what they do. With only a month on board I’m extremely impressed with not only the attention we are given but with how quickly things are progressing. They’ve taken the time to really understand our business and are by far exceeding expectations.
Dr. Mohammad, M.D.
Arlene Howard is one of the best, if not the best, in her field. She has been in the business for a long time, which means she's very well connected and knows all the ins and outs. She doesn't accept anyone that just walks into her office, but when and if you are fortunate enough to be her client, she will love you and she will fight for you. Can't be more grateful to work with Arlene.
Kien Vuu MD
