PSC FDA Clinical Trials Programs
PSC is committed to two formal programs at this time but may expand as data and resources become available.
The first program is for knee osteoarthritis. This program is based upon our veterinary clinical data in which have treated over 5,000 canine patients with osteoarthritis in multiple joints, including the knee. Our veterinary clinical trials have provided safety, dosing, and treatment success data over a 15 year period that has allowed to progress rapidly into our human treatment programs.
Our second major program is for chronic Traumatic Brain Injury (TBI). This is a devastating condition that is all to common in automobile crashes, sports injuries, and in the military. This program will use intravenous stem cell therapy (your own cells) to attempt to reduce the inflammation and degeneration of the brain.
Traumatic Brain Injury
PSC FDA Osteoarthritis Clinical Trials Program
PSC is committed to a formal clinical trials program leading to an FDA approval.
PSC has already completed an FDA clinical trial for osteoarthritis.
Phase 2a FDA Trial for Safety and Preliminary Efficacy
This study enrolled 40 patients and was completed and submitted to the FDA. This trial demonstrated solid safety and a preliminary signal of efficacy. From this data we are submitting a randomized controlled trial with a larger group and placebo controlled and will be conducting this single knee osteoarthritis study in 2024-2025.
- No serious adverse events
- Improvement in KOOS knee function scores
- Overall XX% satisfaction
PSC FDA Traumatic Brain Injury Clinical Trials Program
PSC is submitting a new application to begin treating TBI patients in a phase 1 clinical trial. PSC expects approval and study start early in 2024.
Phase 1 FDA Trial for Safety and Preliminary Efficacy
This study intends to enroll up to 20 patients with chronic traumatic brain injury. The enrollment criteria have not been established with FDA at this time. You may contact us to be put on a candidate list and you will be notified as we near time for enrollment screening.
The is data in the literature and in published clinical trials that stem cells given intravenously may help treat the underlying brain inflammation and improve the clinical symptoms in TBI patients.