A clinical trial to assess the safety and efficacy of stem cell therapy for treatment-resistant bipolar depression launched recently at The University of Texas Health Science Center at Houston (UTHealth).
“Since mesenchymal stem cells are known to counteract inflammation and promote neurogenesis, we are hopeful that they provide an innovative therapy for patients with treatment-resistant bipolar depression,” said Jair Soares, MD, PhD, chair of Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences in McGovern Medical School at UTHealth. “Depending on the results, these stem cells could reduce morbidity and mortality associated with the disease.”
Bipolar disorder is characterized by dramatic shifts in mood, energy, and activity levels that can affect a person’s ability to carry out daily tasks, according to the National Institute of Mental Health. People with the disorder can swing from depression to mania. An estimated 2.8% of U.S. adults had bipolar disorder in 2016, and a large portion of them do not have a satisfactory response to available treatments.
This double-blind, randomized, placebo-controlled trial will use allogenic mesenchymal stem cells, which are multipotent stem cells taken from a bone marrow donor. The mesenchymal stem cells are manufactured in the Judith R. Hoffberger Cellular Therapeutics Laboratory at UTHealth, a state-of-the-art Food and Drug Administration-registered facility designed to comply with current Good Manufacturing Practice.
In a 2010 study published in Translational Research, scientists reported that stem cells showed efficacy in neurodegenerative illnesses that share several biological underpinnings of bipolar disorder, such as Parkinson’s disease, with no adverse effects.
In previously published studies by researchers at UTHealth, stem cells have shown a dampening effect on inflammation, which has been linked to bipolar disease. Inflammatory markers have also been associated with a decreased likelihood of response to treatment in people with bipolar disease.
The trial will enroll 30 patients, who will receive a single injection of either the stem cell product or placebo and continue to receive their usual care for bipolar depression for the eight weeks of the study.
Soares sees patients at UT Physicians, the clinical practice of McGovern Medical School.
McGovern Medical School co-investigators are Charles S. Cox Jr., MD; Fabio Triolo, PhD; Marsal Sanches, MD, PhD; João de Quevedo MD, PhD; Sudhakar Selvaraj, MD, PhD; Antonio Teixeira Jr., MD, PhD; and Benson M. Irungu, PhD. Cox is a professor and George and Cynthia Mitchell Distinguished Chair in Neurosciences in the Department of Pediatric Surgery. Triolo is an associate professor and the Clare A. Glassell Distinguished Chair in the Department of Pediatric Surgery. De Quevedo and Teixeira are professors; Sanches and Selvaraj are associate professors; and Irungu is an assistant professor in the Faillace Department of Psychiatry and Behavioral Sciences.
Soares, Cox, Triolo, and de Quevedo are also members of The University of Texas MD Anderson UTHealth Graduate School of Biomedical Sciences.