Hope Biosciences Opens First Phase I/II Stem Cell Trial for Brain Injury Treatment

By the Hope Biosciences Editorial Team

HOUSTON, TX, October 16, 2019 – Hope Biosciences, a clinical stage biotechnology company focused on developing cell-based therapeutics for acute and chronic diseases, today announced that enrollment is now open for a Phase I/II trial evaluating safety and efficacy of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) for Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy (brain injury caused by oxygen deprivation to the brain), in partnership with The University of Texas Health Science Center at Houston (UTHealth).

“We are pleased to announce this study—the first Phase I/II trial to use HB-adMSCs for TBI/HIE—in partnership with our esteemed colleague, Charles Cox, Jr., M.D., and his team at UTHealth. The promise of cell therapy is so evident, but it has always been limited by the inability to provide enough cells to make a significant, lasting impact. This trial is novel in that it overcomes these limitations. Due to our proprietary technology, we can now create, on demand, virtually unlimited doses of autologous mesenchymal stem cells from a single tablespoon of a patient’s fat. This completely revolutionizes the way we can deal with chronic degenerative diseases while eliminating donor rejection and donor-to-donor variability,” said Donna Chang, President and CEO of Hope Biosciences.

There are currently no therapies that have shown clinical benefit in chronic TBI and Hope Biosciences is committed to changing this. Chronic neuroinflammation has been demonstrated after neurological injury for up to 13 years in patients after TBI and is associated with progressive white matter loss. HB-adMSCs are anticipated to provide immunomodulation to reduce chronic microglial activation as measured by [11C]ER-176 uptake value measurements globally and in the thalamus. Overall results are anticipated to be a decrease in neuronal cell loss and improvements in neurocognitive outcomes (improvements in verbal response, motor function, and memory, that correlate to physical changes in the brain).

“We have focused our approach using cell therapy on patients with measurable microglial activation (neuroinflammation) as determined by advanced imaging techniques. We hope that this will inform us regarding the overarching strategy of targeting the neuroinflammatory response to injury using cell-based therapies,” said Dr. Charles S. Cox, Jr., George & Cynthia Mitchell Distinguished Chair in Neurosciences, Department of Pediatric Surgery at McGovern Medical School at UTHealth. Cox is the director of the Program in Children's Regenerative Medicine and Co-Director of the Memorial Hermann Red Duke Trauma Institute.

This Phase I/II study is a single arm, non-randomized study that is expected to enroll 24 participants. The study’s primary objective is to determine the safety and treatment effect of HB-adMSCs for treatment of sub-acute and chronic traumatic brain injury and hypoxic-ischemic encephalopathy (TBI/HIE). HB-adMSCs are administered via three intravenous infusions over a six-week period and follow-up evaluations at six months and one-year post-infusion. HB-adMSCs are autologous and have an established safety profile.

Hope Biosciences and UTHealth are now recruiting participants; for more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT04063215.