Personalized Stem Cells, Inc.
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…
Inclusion Criteria: 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, Hepatitis B or C Active cancer Significant cardiovascular pathology Hyp…
culture-expanded adipose stem cells
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.