Better Quality Cells
Personalized Stem Cells, Inc. (PSC) provides autologous adipose-derived stem cell services to physicians participating in PSC clinical trials approved by the FDA.
- Quality testing including sterility, endotoxin, cell count, identity, and viability
- Reduced staff time and effort compared with “in-clinic” adipose processing
- Doses shipped frozen and are thawed at room temperature with no processing required
- Potential for future cell therapy per patient from cultured cells
- GMP compliant processing
- FDA approved clinical trial protocols
- Clinical trial training and support
FDA Compliant Manufacturing
Recent FDA enforcement actions have impacted hundreds of physician’s ability to offer stem cell therapy (Example 1, Example 2, Example 3). Inspections have led to deficiency citations (483s), warning letters, and US Justice Department permanent injunction lawsuits against physicians. PSC provides stem cells to IND enrolled physicians in order to provide physicians with a dependable, FDA compliant source for stem cell processing.
Forthcoming Studies
We are currently conducting clinical trials for treatment of arthritis. In 2020 we plan to apply to the FDA for treatment of Back Pain and Traumatic Brian Injury.