More Cells, More Brains, More Hope

As 2026 progresses, so, too, does research exploring Hope Biosciences’ proprietary cellular therapeutics in brain injury. Calendar year 2026 commenced with our cells at work in a Phase II clinical trial in Traumatic Brain Injury (TBI) executed by UTHealth Houston; early summer brought peer-reviewed publication in globe-leading neurology journal Brain of results of another TBI trial using our cells; and as summer presses on, we are delighted to begin manufacturing treatments for a protocol in brain injury (BI) conducted by and at Hope Biosciences Research Foundation (HBRF).

Updates and information about each are in sections below, including a trial currently enrolling. Why does it matter? Looking at multiple protocols together demonstrates how a suite of research progresses patient care in the field. Supporting multiple protocols of varying sizes, in patient populations with differing degrees of injury or disease severity, dramatically increases the data pool. Taken together, an increasingly clear picture emerges of how and when an investigational therapeutic is most effective. That picture in turn informs how the next protocol is designed, more patients studied, more people reached. Momentum gathers, which is an exciting experience as we press forward toward a practical healthcare solution for people in need.

Here are three places Hope Bio’s cells are working as you read:

CURRENTLY ENROLLING: Phase II Clinical Trial in Traumatic Brain Injury

Enrollment is open at UTHealth Houston and UTHealth San Antonio for a 51-participant, FDA-authorized double-blind placebo-controlled Phase II clinical trial to evaluate if intravenously infused Hope Biosciences autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) affect brain structure, neurocognitive and functional outcomes, and/or neuroinflammation after traumatic brain injury (TBI) in adults.

The Department of Defense (DoD)-funded trial marks the second collaboration between UTHealth Houston and Hope Bio. Preliminary results of a previously completed 24-patient open label Phase I/IIa study yielded clinically significant effects in imaging biomarkers, and patient-reported outcomes. (The first study is the one that was recently published – keep reading for details!)

Participants can be aged 18 to 55 years, with functional damage from closed head trauma unlikely to improve with present standards of care. Diagnosis must be greater than six months, with a Glasgow Outcome Scale-Extended score greater than “2” and less than or equal to “6.” There is no cost to participate.

For up-to-date clinical trial information, please watch the video below and visit clinicaltrials.gov (NCT05951777) for site contact information.

https://www.youtube.com/watch?v=S0Vo_PJhwRc

PUBLISHED: Phase I/2a Clinical Trial in Traumatic Brain Injury

Summer got off to a sizzling start in this research area, with publication of results from the previously mentioned Phase I/IIa TBI study in Oxford University Press's Brain, one of the world’s leading neurology journals.

The study, conducted by UTHealth Houston (NCT04063215, results posted), assessed the impact of Hope Biosciences’ autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in adult patients with chronic TBI using imaging, functional, and neurocognitive outcome measures. Design was a single center, open label trial for 24 adult patients living with sub-acute or chronic neurological injury at least six months established. Participants received three infusions of 200 million stem cells over a six-week period, spaced 14 days apart, with status monitored and tested for a year following last infusion.

Using advanced PET imaging and MRI technologies, investigators report treatment with Hope Bio’s therapeutic was associated with reduced brain inflammation, improvements in measures of depression, fatigue, and pain, and positive changes in advanced brain imaging biomarkers among adults living with chronic TBI. Treatment correlated with significant reductions in brain immune cell density in regions linked to depression, fatigue, and pain; and brain imaging revealed improvements in measures associated with microstructural brain integrity. The study also concludes a favorable safety profile, with no serious treatment-related adverse events reported.

Check out this video to hear more from the Principal Investigator on this trial, and lead author of the published paper:

https://www.youtube.com/watch?v=eiQx0kBlbvI

NEW! Expanded Access protocol in Brain Injury

This seven-patient Expanded Access protocol (NCT07164482) is run by independent clinical research organization HBRF at their site in Sugar Land, Texas. The protocol is open label, which means all participants receive the cellular therapeutic under evaluation, manufactured by Hope Biosciences. The study dictates a sixteen-week active treatment period, during which patients will receive six treatments at approximately two-week intervals.

As Donna Chang, President, HBRF, shared in a press release:

"Currently enrolled are individuals ranging between 14 and nearly 90 years of age. Their stories vary, and include brain injury resultant from extensive hypoxic injury, including suffered by a mother during childbirth; falls with head strike; motor vehicle and bicycle accidents; and from violent assault. Each of these men and women live with tremendously complicated, highly individualized medical pictures and healthcare needs. We have seen resoundingly positive results in chronic traumatic brain injury using imaging, functional, and neurocognitive outcome measures in other FDA-authorized clinical trials. We have every reason to believe the same can be achieved here with more diverse inclusion of injury nexus, and a greater degree of injury severity. We will measure an array of clinical endpoints, but our most sincere hope is to improve quality of life for each participant."

For up-to-date clinical trial information, please visit hopebio.org, or reach out directly to HBRF by writing to clinical@hopebio.org or calling (346) 900-0340.

Bonus

This conversation demonstrates the benefits of considering multiple studies together. Even more broadly, considering research in similar conditions can also lead to powerful progress. Brain injury, for example, shares the characteristic of neuroinflammation with neurodegenerative diseases such as dementia, Parkinson’s, and others. Hope Bio is optimistic that other trials underway, including a protocol in early onset Alzheimer’s Disease, will continue to yield beneficial insights that can be applied to brain injury studies.

The bottom line

We use the term “hope-filled update(s)” a fair amount around Hope Bio, because that’s exactly what this news is – hope-filled. Stay tuned for more, in brain injury and other conditions. Onward we press, together.

Pictured: work continues in the labs at Hope Biosciences, all day, every day - for individuals living with brain injury, countless other disease and injury conditions, and for you and your loved ones.