Innovative Clinical Trial to Test Stem Cells for Reducing Alcohol Intake and Mood Symptoms
Along with education and clinical care, the University of Miami Miller School of Medicine Department of Psychiatry & Behavioral Sciences conducts research into a wide range of disorders. “We have a number of ongoing clinical trials into depression, anxiety, addictions, post-traumatic stress disorders and other issues,” said Gabriela Vargas, M.B.A., project manager of the Behavioral Research Assessment Center. “Our investigators are making significant contributions to understanding these conditions.”
Now, the department is enrolling participants in a new study to evaluate whether stem cells can reduce alcohol intake and mood symptoms through their anti-inflammatory mechanisms. “Stem cells are a novel treatment pioneered at the University of Miami to treat a variety of inflammatory conditions,” said Ihsan Salloum, M.D., M.P.H., chief of the Division of Alcohol and Drug Abuse. “Now, we are looking at whether they can deliver similar benefits for these disorders.”
Recent scientific studies have focused on the connection between inflammation and alterations to the immune system in both clinical depression and chronic excessive alcohol drinking. Inflammation appears to be a factor in both disorders, while depression and excessive drinking, in turn, may increase inflammation in the brain.
Dr. Salloum is the principal investigator for the ALAUNUS study: “A Phase I/II, Prospective, Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients with Comorbid Alcohol Use Disorder and Major Depression (AUD-MD).”
Eligible participants who have a co-diagnosis of major depression and alcohol use disorder and who show signs of high inflammation will be randomized to receive either a stem cell or placebo infusion. Following infusion, subjects will be followed at two-week intervals for 12 weeks, then at 6 months, 9 months, and 12 months after infusion.
“If successful, this treatment would represent a paradigm shift in treating complex conditions, in which inflammatory mechanisms are altered,” said Dr. Salloum. “It could open the door to a new strategy for treating comorbid alcoholism and major depression.”
For more information about this study, call 305-243-5840 or visit https://clinicaltrials.gov/ct2/show/NCT03265808?term=salloum&cntry=US&state=US%3AFL&city=Miami&draw=1&rank=3