Safety Study of Intravenous Allogeneic Umbilical Cord Stem Cell Treatment for Idiopathic Pulmonary Fibrosis

What this Trial Is About

This research aims to evaluate the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells to treat Idiopathic Pulmonary Fibrosis IPF. The study is a Phase 1 trial focusing on patients diagnosed with IPF, investigating the potential benefits and risks of this stem cell treatment. For patients with more severe disease requiring chemotherapy drugs like methotrexate, an additional treatment using an autologous T Cell vaccine made from the patients own T cells will be used. Participants will receive a single intravenous infusion containing a total dose of 100 million cultured stem cells. The trial includes monitoring patients over a long period, with evaluations occurring one month before treatment and then at 1, 6, 12, 24, 36, and 48 months after treatment. Those needing chemotherapy will receive the T Cell vaccine created through apheresis of their own T cells. Throughout the study, patients will undergo safety assessments to monitor adverse events and efficacy evaluations including lung function tests like forced vital capacity and oxygen saturation tests. This follow-up will last for four years post infusion to carefully observe treatment effects and patient health. Participants will be closely monitored through scheduled visits to track their progress and any potential side effects.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF