Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
NCT05018416 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2026-03-13
Summary
The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).
Conditions
- Chronic Kidney Diseases
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
Interventions
- BIOLOGICAL
-
Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Sponsors & Collaborators
-
Prokidney
lead INDUSTRY
Principal Investigators
-
Catherine Taylor · Prokidney
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-27
- Primary Completion
- 2025-05-20
- Completion
- 2025-05-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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