Performance Cell Manufacturing (PCM) recently completed a stem cell manufacturing contract for an FDA approved stem cell clinical trial for knee osteoarthritis. Manufacturing for the trial included processing adipose tissue (lipoaspirate) from 38 patients to produce autologous stem cell doses suitable for intra-articular injection. Release specifications included cell count, viability, sterility, endotoxin, and cell identity by flow cytometry. Doses of stem cells meeting the release criteria were shipped to seven clinical sites in the U.S.
As part of the manufacturing contract, PCM has also stored extra stem cell doses from clinical trial participants. According to Personalized Stem Cells, Inc (PSC), the human adipose-derived stem cell company conducting the clinical trial, these stem cells may be culture expanded in the future to create additional doses of cells for potential future treatments for these patients in another approved clinical trial.
PCM was formed as the contract development and manufacturing division of VetStem Biopharma after being contacted by cell therapy companies in San Diego seeking a responsive and experienced Contract Development Manufacturing Organization (CDMO) for development and production of cells for FDA approved clinical trials. Founder and CEO, Dr. Bob Harman, stated, “After over 15 years of regulatory and cell manufacturing experience, and multiple contract manufacturing collaborations, it became clear that we could potentially fill a specific niche in the industry. We are small enough to provide personal attention, with the expertise to accelerate development and scale up manufacturing of cell therapy products.”