Trials / Completed
CompletedNCT05018416
Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Prokidney · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The objective 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): * Cohort 1: Two scheduled REACT/ rilparencel injections given 3 months (+60 days) with at least 18- month follow-up * Cohort 2: One scheduled REACT/ rilparencel injection with a possible second REACT/ rilparencel injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT/ rilparencel injection). Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Renal Autologous Cell Therapy (REACT) | Autologous selected renal cells (SRC) |
Timeline
- Start date
- 2021-07-27
- Primary completion
- 2025-05-20
- Completion
- 2025-05-20
- First posted
- 2021-08-24
- Last updated
- 2026-03-13
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05018416. Inclusion in this directory is not an endorsement.