Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
• Fully understand and sign the informed consent form;
• Age ≥18 years and \<80 years;
• Good physical condition (WHO performance status score 0-1);
• Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
• Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
• Screening period LENT-SOMA score ≥1;
• Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.