Personalized Stem Cells Receives FDA Approval for Novel Stem Cell Treatment Clinical Trial for Traumatic Brain Injury

Personalized Stem Cells, Inc. receives FDA approval to begin a clinical trial using patients’ own stem cells to treat traumatic brain injury.

POWAY, CA, UNITED STATES, October 13, 2026 /EINPresswire.com/ — Personalized Stem Cells, Inc (PSC), received approval from the U.S. Food and Drug Administration on May 21, 2026 to proceed with an Investigational New Drug (IND) application for the treatment of traumatic brain injury with a patient’s own stem cells. The trial will enroll 10 patients selected from retired US Special Forces and PSC has now opened enrollment. The study is led by principal investigators Robert Bray, MD and Peter Hanson, MD and the study will be conducted at the DISC Surgery Center in Carlsbad, California.

The IND was reviewed by FDA’s Center for Biologics Evaluation and Research and is filed under clinical protocol PSC-CP-012. The study evaluates intravenously administered autologous adipose-derived mesenchymal stem cells (MSCs) in adults with persistent post-concussive symptoms following one or more traumatic brain injuries. PSC has submitted a request for Fast Track designation for the program.

Traumatic brain injury affects approximately 2.5 million Americans annually. For a subset of those patients, cognitive, behavioral, and physical symptoms persist well beyond the expected window of recovery. There is currently no approved disease-modifying therapy for this population.

The therapy under investigation is autologous meaning the cells are collected from the patient’s own adipose tissue, culture-expanded to cGMP standard at PSC’s FDA-registered facility and returned by intravenous infusion under the study protocol. Because the cells originate with the patient, the approach does not carry the donor-matching, immune-rejection, or immunosuppression considerations associated with donor-derived cell therapy.

PSC Chief Medical Officer, Christopher Rogers, MD, stated, “Patients with persistent post-concussive symptoms have very few options once conventional management is exhausted. This trial is designed to evaluate whether a patient’s own mesenchymal stem cells, delivered intravenously, can be administered safely in this population and what effect they have on symptom burden. Our past studies in knee osteoarthritis and COVID-19 therapy provide the foundation for moving into this new therapeutic area.”

The program builds on more than twenty years of autologous adipose-derived MSC manufacturing and clinical experience at VetStem, Inc., PSC’s affiliated veterinary regenerative medicine company, which has treated more than 17,000 animals using the same cell type and the same manufacturing methodology. That body of real-world manufacturing and safety data supported PSC’s regulatory submissions and its progression into this third human clinical study.

PSC CEO, Bob Harman, DVM, MPVM, stated, “We spent nearly two decades proving this manufacturing platform and clinical safety in animals before we brought it to people. TBI is a largely unmet medical need, and we believe this approach of using a patient’s own stem cells to support healing will prove to be safe and effective in this and subsequent clinical trials as we work toward FDA approval.”

PSC has an investment capital raise in progress. For those interested in more information about becoming involved with PSC, please click here.

About Personalized Stem Cells, Inc.
Personalized Stem Cells was formed in 2018 to advance human regenerative medicine based upon the research of its affiliated company, VetStem, Inc. This privately held biopharmaceutical enterprise, based in Poway, California, develops autologous culture-expanded adipose-derived mesenchymal stem cell therapies and operates an FDA-registered cGMP manufacturing facility.

Robert Harman
Personalized Stem Cells
+1 833-772-3557
info@pscells.com

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