Mild Traumatic Brain InjuryPhase 1NCT07923487
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
A Phase 1 study testing autologous adipose-derived stem cells in people with Mild Traumatic Brain Injury, run by Personalized Stem Cells, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- autologous adipose-derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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, Hepatitis B or C Active cancer Significant cardiovascular pathology Hypertension systolic >160, diastolic >100 Coagulopathy Certain neurological diseases Certain psychiatric diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Safety and Exploratory Efficacy of PSC-05, An Autologous Adipose-Derived Stem Cell Therapy Product, for the Treatment of Chronic Mild Traumatic Brain Injury
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.
Read the detailed description
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- autologous adipose-derived stem cells
- Keywords
- mild traumatic brain injury, chronic concussions, adipose stem cells, autologous
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose-derived stem cellsBiological
culture-expanded adipose stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Single intravenous treatment with PSC-05 Receives: Biological: autologous adipose-derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - adverse event rate
Adverse events
Measured: From Enrollment to Day 90, end of study
Secondary outcomes (1)
Neurobehavioral Symptom Inventory
Measure of post-concussive symptoms
Measured: Treatment Day 0 to Day 90, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SIngle arm, unblinded open label study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Personalized Stem Cells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bray, MD, Principal investigator, DISC Surgery CenterPeter Hanson, MD, Principal investigator, Grossmont Othropedic Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923487
- Sponsor's protocol ID
- PSC-CP-012
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Safety and Exploratory Efficacy of PSC-05, An Autologous Adipose-Derived Stem Cell Therapy Product, for the Treatment of Chronic Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07923487
- Acronym / sponsor ID
- PSC-CP-012
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mild traumatic brain injury, chronic concussions, adipose stem cells, autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Personalized Stem Cells, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SIngle arm, unblinded open label study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: autologous adipose-derived stem cellsSingle intravenous treatment with PSC-05 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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, Hepatitis B or C Active cancer Significant cardiovascular pathology Hypertension systolic >160, diastolic >100 Coagulopathy Certain neurological diseases Certain psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous adipose-derived stem cellsculture-expanded adipose stem cells | Biological | Treatment group |
Primary outcome
Safety - adverse event rate
Time frame: From Enrollment to Day 90, end of study
Adverse events
1 secondary outcome
Neurobehavioral Symptom Inventory
Time frame: Treatment Day 0 to Day 90, end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bray, MD principal investigator
DISC Surgery Center
Peter Hanson, MD principal investigator
Grossmont Othropedic Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous adipose-derived stem cells in people with Mild Traumatic Brain Injury, run by Personalized Stem Cells, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - adverse event rate (time frame: From Enrollment to Day 90, end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.