- Conducted by Vitro Biopharma, the trial aims to investigate the safety and efficacy of intravenous infusions of its stem cell therapy product
Vitro Biopharma is an innovative biotechnology company targeting autoimmune diseases and inflammatory disorders that are derived from culture-expanded mesenchymal stem cells (“MSCs”) sourced from the Wharton’s jelly of umbilical cords. In the United States, Vitro Biopharma is authorized to conduct a clinical trial under a U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) application to assess the safety and efficacy of AlloRx Stem Cell therapy in Pitt Hopkins syndrome (“PTHS”). The PTHS trial will utilize FUJIFILM Irvine Scientific’s PRIME-XV Stem FreezIS DMSO-Free* cryopreservation medium as an excipient during the process.
The use of DMSO during cell therapies has historically been a process critical step used to maintain cell viability during cryopreservation, however DMSO toxicity has been well characterized in cells throughout the human body and can cause a wide range of undesirable side effects following stem cell therapy. FUJIFILM Irvine Scientific’s PRIME-XV Stem FreezIS DMSO-Free* cryopreservation medium is a complete and ready-to-use, chemically defined, animal component- and protein-free solution that does not contain DMSO. The medium is validated for use in mesenchymal stromal cells and CD34+ cells, and optimized cryopreservation protocols for peripheral blood mononuclear cells and T cells have also been published. It is manufactured under GMP conditions and has a drug master file registered with the FDA.
Erik Vaessen, chief business officer at FUJIFILM Irvine Scientific, said "We are pleased to support Vitro Biopharma’s clinical trial via the provision of our PRIME-XV Stem FreezIS DMSO-Free cryopreservation medium. The recent FDA authorization of this trial represents an exciting step forward in cell therapy pipelines, with the potential to remove the DMSO requirement from workflows. We are committed to developing and supplying products that help our customers fully realize the potential of new advanced therapies and improved patient outcomes.”
For more information on FUJIFILM Irvine Scientific’s PRIME-XV Stem FreezIS DMSO-Free* cryopreservation medium, please visit https://www.irvinesci.com/prime-xv-stem-freezis-dmso-free.html
* PRIME-XV Stem FreezIS DMSO-Free is for research use or further manufacturing use only.
