Policy & Regulation
Department of Defense Approves USD 4.9m for Next Phase Traumatic Brain Injury Study Using Hope Biosciences' Stem Cells
2 June 2023 - - A four-year, nearly USD 5m clinical trial grant awarded to UTHealth Houston by the Department of Defense's Office of Congressionally Directed Medical Research Programs (CDMRP) will evaluate if intravenously infused Hope Biosciences' autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) reduce chronic neuroinflammatory response to severe traumatic brain injury, the company said.

The award is a significant positive step toward developing treatment for a currently incurable condition that affects approximately 1.5m Americans every year, killing 50,000 annually.

The Centers for Disease Control reports an estimated 5.3 m people live with permanent TBI-related disability in the US.

More than 460,000 military service members have been diagnosed with TBI since 2000.

Preliminary results from a prior Phase I/IIa, 24-patient study sponsored by Hope Biosciences at UTHealth (NCT04063215) were presented in May during the Cellular Therapies and Transfusion Medicine in Trauma and Critical Care (CTTACC) 2023 Conference in Scottsdale, Arizona.

Repeated intravenous administration of HB-adMSCs demonstrated the potential of reducing chronic neuroinflammation.

This award constitutes the Department of Defense's first support of UTHealth Houston's and Hope Biosciences' collaboration.

The anticipated multi-center Phase II study is set to begin enrollment in September, pending approval by UTHealth Houston's Institutional Review Board.

Headquartered in Sugar Land, Texas and now in its seventh year of operation, to date MSCs cultured at Hope Biosciences have been used in more than 35 FDA-authorized clinical studies covering a wide range of conditions including chronic injury, degenerative diseases and autoimmune diseases.