Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

NCT05018416 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: REGEN-007
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Kidney Biopsy; Renal Autologous Cell Therapy (REACT); rilparencel

Outcome Measures

Primary Outcomes (2)

• Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation

  Screening thru month 28

• Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.

  Screening thru 18 months after the last injection of study drug

Study Arms (2)

2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections

EXPERIMENTAL

Cohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Biological: Renal Autologous Cell Therapy (REACT)

1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection

EXPERIMENTAL

Cohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney.

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

Autologous selected renal cells (SRC)

Also known as: rilparencel

1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection; 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
• Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
• The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
• The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
• The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

You may not qualify if:

• The subject has a history of renal transplantation.
• The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.
• Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
• The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.

Sponsors & Collaborators

• Prokidney: lead

Study Sites (5)

Kidney Associates of Colorado, P.C. - Frenova

Denver, Colorado, 80210-5073, United States

Location

Nephrology Associates

Newark, Delaware, 19713, United States

Location

Boise Kidney and Hypertension Institute - Frenova

Nampa, Idaho, 83687, United States

Location

Paragon Health, PC d/b/a Nephrology Center, PC - Frenova

Kalamazoo, Michigan, 49007-3889, United States

Location

Nephrology and Hypertension Associates Ltd - Frenova

Tupelo, Mississippi, 38801-6560, United States

Location

Related Publications (1)

• Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2. doi: 10.2215/CJN.0000000969. Online ahead of print. No abstract available.

  PMID: 41481370 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Catherine Taylor

  Prokidney

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: July 27, 2021
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)