We believe that we can jumpstart human stem cell therapy using the VetStem GMP manufacturing capabilities, extensive preclinical data, and experience.
POWAY, Calif. (PRWEB) June 18, 2019
Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has submitted an Investigational New Drug (IND) application to the FDA for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. The first clinical trial uses stem cells as a treatment of osteoarthritis in the knee. This IND is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, regulated quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA-IND approved clinical trials starting with uses in orthopedics and expanding to other medical conditions in the future.
PSC has contracted with VetStem Biopharma for cGMP stem cell manufacturing for use in Phase I/II human trials by the PSC network of physicians. PSC has also licensed the VetStem patent portfolio and intellectual property for use of adipose-derived regenerative cells.
The current environment of in-office, unregulated manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards. It is clear that the only allowed use of stem cells will be through legitimate FDA clinical trials with manufacturing in a controlled FDA inspected, GMP compliant facility. Qualified physicians enrolled in the PSC network will have access to quality manufactured, safety tested cells for use in FDA approved clinical trials. They will also be able to share their experiences with other PSC network physicians in order to better define and implement the highest quality treatment options in the future.
PSC was founded by Robert Harman, DVM, MPVM and Michael Dale, both of whom also co-founded VetStem and are both experienced serial entrepreneurs.
“This is a unique opportunity in history to have a profound influence on the development and adoption of a game-changing medical technology,” says Mr. Dale. “Regenerative medicine may offer help for a wide array of conditions that are not effectively treated with today’s medicines.”
“We believe that we can jumpstart human stem cell therapy using the VetStem GMP manufacturing capabilities, extensive preclinical data, and experience. Mr. Dale will rapidly lead PSC forward with legitimate FDA approved clinical trials,” says Dr. Harman.
About Personalized Stem Cells, Inc.
Personalized Stem Cells was formed in 2018 to advance and legitimize human regenerative medicine. This privately held biopharmaceutical enterprise, based near San Diego (California), offers qualified physicians who enroll, an FDA compliant autologous stem cell product (from patient’s own fat tissue) for use in FDA approved clinical trials. PSC is driving development and adoption of stem cell and regenerative medicine within the FDA-IND process by providing quality manufactured, safety tested cells, and well-defined clinical trials. PSC has licensed a portfolio of over 70 issued patents in the field of regenerative medicine.