NCT06790498

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Prokidney · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

Detailed description

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.

Conditions

• Diabetic Kidney Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Renal Autologous Cell Therapy (REACT)	No interventions in this trial

Timeline

• Start date: 2023-11-23
• Primary completion: 2030-05-31
• Completion: 2030-08-31
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study