StemReady™ and Early Access Programs
You may qualify for enrollment.
FDA program for early access outside of a formal trial – FDA must approve.
Federal Right-to-Try act
Federal Law to allow access to investigational drugs ( your cells) when other options not available.
We take every precaution to ensure that each patients’ cells are tested for quality and safety.
PSC stem cell processing is compliant with US FDA GMP regulations.
PSC is an FDA registered Tissue Bank.
Traumatic Brain Injury
Early access: PSC FDA Clinical Trials Programs
PSC is committed to a formal clinical trials program leading to an FDA approval.
What happens then?
Any patient with stored cells can work with their physician for use in any disease or condition that the physician determines is appropriate – this is allowed by the “Off Label Use” federal and state laws.
PSC is committed to two formal programs at this time but may expand as data and resources become available.
You may contact us at any time to discuss if you might qualify for one of our current or upcoming trials. If you do not have one of the conditions on the left, contact us about the Early Access Program called Federal Right-to-Try.
Early access: FDA Compassionate Use (Expanded Access)
FDA has made available to companies with investigational drugs the opportunity to provide these experimental drugs to patients outside of the FDA clinical trials program.
FDA must approve any compassionate use request. Generally, these programs are closely related to the current PSC clinical trials. Examples include:
- Traumatic Brain Injury
Early access: Federal Right-to-Try Program
The Federal Government passed the “Right-to-Try” Act in 2018. It was intended to give broader access to investigational drugs to patient in real need that had exhausted other treatment options for their severe or debilitating disease. To qualify:
- Patient must have life-threatening or severe debilitating condition
- Focus will be on orthopedic conditions
- FDA does not approve each application
- You, your doctor, and PSC must all agree on the plan
- Your doctor is encouraged to participate because the RTT Act removes their liability from assisting you