A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004

What this Trial Is About

This research aims to evaluate the long-term safety of up to two injections of a gelatin-hydrogel formulation called Renal Autologous Cell Therapy REACT, given 3 to 6 months apart into the same kidney. The study focuses on participants with chronic kidney disease CKD who have previously received REACT in earlier clinical trials. The goal is to monitor how these treatments affect kidney function over time. This observational extension study involves up to 80 participants who were treated with REACT in prior interventional studies RMCL-002, REGEN-003, REGEN-004. Participants will be followed for up to five years through a series of alternating in-clinic and phone visits. No new treatments are given during this study rather, it is designed to observe the long-term effects after prior exposure to REACT. During the study, participants will undergo regular assessments to monitor kidney function and safety outcomes. Researchers will measure kidney function decline, dialysis requirements, and kidney transplant events over a 60-month period from the end of the previous trial. The study includes various safety checks and long-term follow-up to understand how REACT affects participants over several years.

A Long-Term Follow-Up Study of Participants Exposed to REACT