Personalized Stem Cells

About Personalized Stem Cells

Personalized Stem Cells (PSC), Inc. is a biopharmaceutical company established in 2018 with a focus on advancing regenerative medicine through FDA-regulated clinical pathways. The company was co-founded by Robert Harman, DVM, MPVM, and Michael Dale, both experienced serial entrepreneurs who previously co-founded VetStem Biopharma. Dr. Harman, who serves as CEO, brings over two decades of executive experience in biotechnology. His journey into stem cell therapy was sparked by witnessing its potential in veterinary medicine, leading him to first establish VetStem for animals and later PSC to translate these successes to human applications under the "One Medicine" philosophy.

Based near San Diego, California, PSC operates as a biotechnology firm centered on developing treatments for serious human conditions by providing physicians with an FDA-compliant autologous stem cell product for use in approved clinical trials. The company's business model involves working within the strict regulatory framework of the FDA to offer an alternative to the unregulated stem cell therapies that have faced scrutiny. PSC's services include the processing of a patient's own fat (adipose) tissue, harvested via a liposuction procedure, in its FDA-inspected, cGMP-compliant laboratory to isolate and extract mesenchymal stem cells (MSCs). These cells are then provided to physicians enrolled in PSC's clinical trials for administration back to the same patient. Additionally, the company offers stem cell banking, allowing individuals to store their multiplied cells for future therapeutic use.

A significant milestone was achieved in July 2019, when PSC received FDA approval for an Investigational New Drug (IND) application to treat osteoarthritis of the knee using a patient's own stem cells. This marked the company's first of several planned clinical trials aimed at various conditions, including back pain and traumatic brain injury. The company has also engaged in research for other applications, receiving FDA approval in 2020 for a clinical trial to treat COVID-19 patients and subsequently entering into a licensing agreement with Sorrento Therapeutics for its allogeneic stem cell program. By adhering to rigorous FDA clinical trial processes, PSC aims to generate high-quality data to secure formal approval, making validated stem cell therapies accessible to patients with limited treatment options.