Phase 2a Randomized Study of Autologous Adipose-Derived Mesenchymal Stem Cell Infusions for Adults with Chronic Traumatic Brain Injury Aged 18 to 55

What this Trial Is About

Researchers are studying the safety and potential treatment effects of intravenous infusions of autologous adipose-derived mesenchymal stem cells HB-adMSCs in adults aged 18 to 55 with chronic traumatic brain injury. This phase 2a, randomized, double-blind, placebo-controlled study aims to evaluate changes in brain structure, cognitive and functional outcomes, and neuroinflammation following treatment. Participants will receive three intravenous infusions of HB-adMSCs, each containing 2 x 108 cells, or a placebo of normal saline. These infusions are administered over six weeks with 14-day intervals between each dose. After each infusion, participants are monitored for at least one hour for any infusion-related side effects, with a telephone follow-up 24 hours later. Safety will also be assessed during clinic visits at 6 and 12 months and by phone at 2 years after the last infusion. During the study, participants will undergo multiple assessments including blood tests to monitor various biochemical markers, brain imaging such as MRI and PETDT-MRI, and several neurocognitive and functional tests. Researchers will track changes from baseline at different timepoints up to one year post-infusion. Questionnaires on quality of life and symptom inventories will also be used. The total participation period may extend to two years for long-term safety and outcome monitoring.

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury