Hope Biosciences Deploying New Cellular Therapeutic for Acute Kidney Injury

FOR IMMEDIATE RELEASE

By Jan Shultis

Sugar Land, Texas, 3 February 2026 - A multicenter trial stretching across the southwestern United States is now recruiting patients to investigate whether allogeneic (donor-derived) Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) can prevent progression of trauma-induced Acute Kidney Injury (AKI), an abrupt decline in renal function that occurs over hours to days in up to 50% of trauma and burn patients and has few effective therapies apart from supportive care.

The FDA-authorized Phase 1/2a trial (NCT06654193) will enroll a total of 70 patients across clinical trial sites at the University of Alabama at Birmingham, the University of California at San Francisco, and the University of Texas Health Science Center, Houston. Supporting agencies include the Department of Defense via Medical Technology Enterprise Consortium (MTEC) and Wake Forest Institute for Regenerative Medicine. During the first phase, an initial safety study, 10 patients will receive the therapeutic within 24 hours of consent in three doses, each 24 hours apart. The second phase is a randomized, double-blind, placebo-controlled design through which 30 patients will receive treatment at the same dosage, and 30 patients will receive placebo.

“This trial is an important ‘first’ for us in translational injury research and marks a return of our therapeutic to an emergency setting,” says Donna Chang, CEO, Hope Biosciences. “We have worked in emergency settings before, most notably during the first months of the COVID pandemic, but this trial represents an opportunity to affect broader advancements in how we use cellular therapeutics in cases of acute traumatic injury.”

The AKI trial also marks the first time Hope Biosciences, globally known for use of fresh stem cells treatments manufactured to a previously unprecedented degree of volume and viability, will deploy a frozen stem cell product.

“We remain strong advocates of delivering fresh stem cell treatments, but the urgency of AKI makes administration of fresh cells a logistical improbability. What we really specialize in is standardization of treatment,” elaborates Chang. “From a technical standpoint, we are most concerned with potency when developing a consistent frozen product. We are extremely pleased by what we have been able to validate throughout the development process. From a human perspective, the motivation for creating a frozen product is the same as it is for any other therapeutic advancement - it is a privilege, always, to develop science in service to people. We look forward to finding out how and to what extent our frozen therapeutic can help.”

Primary outcomes to be studied include safety and duration of AKI at Stage 2 more than two days after the start of treatment. Secondary outcomes include potential progression from Stage 2 to Stage 3 AKI, the point at which renal replacement therapy is often initiated; post-injury organ function; severity of complications; hospital-, intensive care- and ventilator-free days; and mortality. Participants must be severely injured trauma or burn patients who have developed Stage 2 AKI within the first ten days after injury and meet specified trauma thresholds. Both men and women aged 18 to 75 years are eligible, barring certain pre-existing or concurrent conditions. At the time of this writing, the site in Houston is actively recruiting; Birmingham and San Francisco are expected to follow soon.

For detailed participant information, please reference the study listing found here (click link to read).

About Hope Biosciences

Hope Biosciences, headquartered in Sugar Land, TX, is a leading cGMP compliant biopharmaceutical research and manufacturing company delivering safe, effective, and affordable stem cell solutions for degenerative and chronic conditions, and is the only clinical-grade facility in the nation offering private banking services for both adults and newborns from around the world.

Hope Bio uses proprietary technology to culture and expand mesenchymal stem cells, a type of adult stem cell found in many tissues in the body and in the placenta of newborns, to unprecedented volume and levels of viability. To date, Hope Bio’s cells have been put to work in nearly 50 FDA-authorized protocols for conditions and diseases currently considered “incurable” and affecting substantial portions of the American population, including two Department of Defense-supported clinical trials.