A Phase 1 interventional study of autologous adipose-derived stem cells in Mild Traumatic Brain Injury, sponsored by Personalized Stem Cells, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Personalized Stem Cells, Inc. · Phase 1, Interventional, and Treatment
This study is a pilot single arm, Phase 1b study of the safety and preliminary efficacy of PSC-05, an adipose-derived autologous mesenchymal stem cell for the treatment of chronic mTBI. This study will focus on United States military special forces operators.
Mild traumatic brain injury (mTBI) is generally associated with a good recovery; however between 15% and 25% patients develop chronic issues. This is of greater concern in individuals with a history of multiple mTBI's and in contact sports where there is risk for long-term neurological disorders. To date there are no FDA approved treatments for these patients. The purpose of this clinical study is to evaluate the safety of an intravenous injection of an investigational biologic product (IBP), PSC-05, the subject's own adipose-derived stem cells, to treat the persistent neurobehavioral symptoms related to chronic mTBI. Safety will be assessed at Day 30 and Termination of the study. The secondary objective is to get initial data on efficacy of the PSC-05 by comparing baseline to Day 30 and Day 90 using cognitive assessment tools and subject self-reported questionnaires. The NSI will be the principal efficacy assessment tool for assessing study endpoint. The purpose of conducting the study is to provide clinical safety data for leading to larger clinical studies to evaluate dose and efficacy and this data will be used for FDA IND filings and pursuit of a BLA.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 10 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →Personalized Stem Cells, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Consent Age 18-65 History of mild TBI greater than 90 days prior to enrollment Acute symptoms ACRM) Biomechanics event (ACRM) Suitability for cell therapy
Exclusion Criteria:
TBI less than 90 days from enrrollment TBI severity greater than mild Coagulation disorders DVT or pulmonary embolism history Stent placement in last 12 months Known alcohol or drug abuse in last 24 months Current specific psychiatric symptoms Laboratory safety assessments clinically out of range Infectious diseases: HIV1, HIV2, or C Active cancer Significant cardiovascular pathology Hypertension systolic >160, diastolic >100 Coagulopathy Certain neurological diseases Certain psychiatric diseases
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single intravenous treatment with PSC-05
Biological: autologous adipose-derived stem cells
culture-expanded adipose stem cells
Safety - adverse event rate
Adverse events
Time frame: From Enrollment to Day 90, end of study
Neurobehavioral Symptom Inventory
Measure of post-concussive symptoms
Time frame: Treatment Day 0 to Day 90, end of study
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2026 (actual). Primary completion is estimated for May 2027, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Personalized Stem Cells, Inc.