Buoyed by promising results of a Phase I study demonstrating the safety of mesenchymal stem cell therapy to treat frailty in older adults, researchers at the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine have taken it a step further.
Now Phase II randomized, placebo-controlled trial findings have verified their initial study, boosting the potential for this stem cell therapy to reverse or forestall the symptoms of frailty. Not only is there no currently approved medical therapy for frailty, the need is expected to grow substantially given the overall aging of the U.S. population.
“It’s a huge need — that’s one of the exciting things,” said Joshua M. Hare, M.D., the Louis Lemberg Professor of Medicine and founding director of ISCI. Frailty is estimated to affect about 10 to 11 percent of seniors, a considerable percentage of the 50 million people older than 65 years experts predict by the year 2050.
Results of the AllogeneiC Human Mesenchymal Stem Cell in Patients with Aging FRailTy via IntravenoUS Delivery (CRATUS) Phase I trial and subsequent CRATUS Phase II trial were simultaneously published online October 12 in The Journals of Gerontology. In an accompanying guest editorial, David G. Le Couter, M.D., Ph.D., professor of medicine at the University of Sydney, and colleagues praised the work.
“These trials represent potential landmarks in the treatment of frailty,” they wrote. “Both studies are early-phase trials of a small number of participants, designed primarily to assess safety, so conclusions about efficacy need to be treated with caution. Even so, the results are striking and, at minimum, pave the way for large randomized Phase III clinical trials.”
“I was very surprised and excited with the results,” Hare said. Replicating their results in the Phase II randomized trials “gives me even greater confidence” in the findings. For example, both trials demonstrated a significant and meaningful increase in six-minute walk tests among older adults with frailty compared to their baseline.
“The idea that we can biologically modify frailty is very exciting,” Hare said. In fact, the research by Hare and his team demonstrate the beneficial effects of mesenchymal stem cell therapy in this population, including their anti-inflammatory effects, pro-regenerative capabilities, and anti-fibrotic actions (meaning they can decrease scar tissue). The investigators have also shown the therapy promotes new vessel growth and improves endothelial function.
“Mesenchymal stem cells are a multifactorial way of offsetting many of the key features of aging,” Hare said.
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