What this study is
Simplified from ClinicalTrials.govTesting a stem cell therapy made from a person's own fat tissue (PSC-05) to learn about its safety and get an early look at whether it works for long-lasting mild traumatic brain injury (a brain injury from a blow or jolt) in United States military special forces operators ages 18 to 65.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- autologous adipose-derived stem cells
Intervention · BIOLOGICAL
culture-expanded adipose stem cells
Study details
- 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
- Sponsor
- Personalized Stem Cells, Inc.
- Conditions
- Mild Traumatic Brain Injury
- Enrolling
- 10 people
- Starts
- 2026-11-01
- Est. completion
- 2027-07-31
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDISC Surgery Center
Carlsbad, California, United States
Study team
Sponsor
Personalized Stem Cells, Inc.
Study ID PSC-CP-012
Principal investigator
Robert Bray, MD
DISC Surgery Center
Principal investigator
Peter Hanson, MD
Grossmont Othropedic Medical Group
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.