NCT03270956

A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Prokidney · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

Detailed description

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Conditions

• Type 2 Diabetes Mellitus
• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Renal Autologous Cell Therapy (REACT)	Autologous selected renal cells (SRC)

Timeline

• Start date: 2018-04-25
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2017-09-01
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study