Study of Intravenous Infusion of Cultured Adult Umbilical Cord Stem Cells to Treat Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Chronic Kidney Disease CKD. This Phase 1 trial is patient-funded and aims to offer insights into the potential benefits and risks associated with this innovative stem cell treatment. For patients with more severe CKD, a different treatment using autologous Effector cells made from their own activated lymphocytes obtained by apheresis will be used. Participants will receive a single intravenous infusion of 100 million UC-MSCs. The study includes thorough monitoring periods before treatment and at multiple time points after treatment 1, 6, 12, 24, 36, and 48 months. This long follow-up helps researchers observe safety and efficacy over time. The alternate treatment for more severe cases involves cells created from the patients own blood. During the study, participants will undergo evaluations including laboratory tests to monitor safety and kidney function. Key measures include tracking adverse events and changes in creatinine levels and estimated glomerular filtration rate eGFR over four years. This comprehensive monitoring aims to provide detailed information on how the stem cell infusion affects participants, ensuring safety and assessing treatment outcomes throughout the study duration.

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