ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion

The proposed study is a single-site, double-blinded, placebo-controlled study involving a single administration of either individual, autologous ATCell™ lines suspended in 5% dextrose lactated Ringer's solution or a vehicle (5% dextrose Lactated Ringer's solution) not containing cells. Each ATCell™ cell line will be created from cells grown from the stromal vascular fraction (SVF) of a participant's own adipose tissue collected by liposuction, and each treated participant will only receive their own cells.

Within the treated group, 3 dosing levels will be explored: 50 million cells, 150 million cells, or 300 million cells, and a Placebo group which will receive 5% dextrose lactated Ringer's solution free of cells. Participant follow-ups will take place 1 day following the tissue harvest procedure and, 1 day, 1 week, 1 month, 3 months, and 6 months following ATCell™ treatment. Comprehensive participant's evaluations involving data collection will take place 1, 3, and 6 months following treatment.

It has been proposed that in general, mild traumatic brain injuries (TBI) events need to be taken far more seriously, and that even mild TBI events can result in lasting negative consequences as evidenced by lower performances on neuropsychological assessments when compared with age-matched controls2. In fact, this condition may eventually lead to Alzheimer's Disease (AD) as well as Chronic Traumatic Encephalopathy (CTE), which, together may be termed the AD-like dementias3, further underscoring the need for effective clinical intervention. Currently, no effective treatments are available for this condition aside from treatment of the symptoms, although some more comprehensive treatments have been proposed.