Mesenchymal Stem Cell Extracellular Vesicles as a New Treatment Paradigm in Solid Abdominal Organ Transplantation: A Case Series

• DOI: 10.1089/scd.2023.0273
• Publication Date: 2024-02-01T14:28:46Z
• Authors: Amy L. Lightner; Masato Fujiki; Mohamed Elshawy; Neda Dadgar; Anita Barnoski; Mohammed Osman; Clifton G. Fulmer; Anil Vaidya
• Keywords: Histopathology

Solid abdominal organ transplantation is fraught with variable rates of rejection and graft versus host disease. We sought to determine the safety efficacy an advanced extracellular vesicle (EV) investigational product (IP) derived from mesenchymal stem cells (MSC) in transplant patient population. Seven separate eINDs were filed FDA for emergency treatment isolated intestinal (n=2), liver allograft modified multivisceral (n=3), GVHD patients (n=2). 15 mL IP was administered intravenously on Day 0, 2, 4 this cycle repeated up four times each depending protocol allowed by FDA. Safety (adverse event reporting) (clinical status, serologies, histopathology) evaluated. There no adverse events related IP. All had improvement clinical symptoms within 24 hours, improved serologic laboratory evaluation, pulmonary dermatologic manifestations GVHD, complete histologic resolution inflammation/rejection 7 days administration. Systemic use a MSC EV successful achieving histological clearance intestinal, inflammation, skin GVHD.