Kidney Week

Abstract: TH-PO1203

Renal Autologous Cell Therapy in Diabetes and CKD

Session Information

• Late-Breaking Research Posters
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Culleton, Bruce F., ProKidney LLC, Winston-Salem, North Carolina, United States

Bruce F. Culleton, MD

• Butler, Emily Lynn, ProKidney LLC, Winston-Salem, North Carolina, United States

Emily Lynn Butler, PhD

• Aqeel, Ahmed, Paragon Health Nephrology Center, Kalamazoo, Michigan, United States

Ahmed Aqeel, MD

• Prakash, Rachita, Kidney Associates of Colorado, Englewood, Colorado, United States

Rachita Prakash, MD, MBBS

• Saad, Theodore F., Nephrology Associates - Delaware Kidney, Newark, Delaware, United States

Theodore F. Saad, MD, FASN

• Silva, Arnold L., Boise Kidney and Hypertension Institute, Boise, Idaho, United States

Arnold L. Silva, MD, PhD

• Wooldridge, Thomas D., Nephhrology and Hypertension Associates, Ltd, Tupelo, Mississippi, United States

Thomas D. Wooldridge, MD

• Yan, Hongxia, ProKidney LLC, Winston-Salem, North Carolina, United States

Hongxia Yan, MS

• Barysauskas, Constance M, ProKidney LLC, Winston-Salem, North Carolina, United States

Constance M Barysauskas, MS

• Stavas, Joseph, ProKidney LLC, Winston-Salem, North Carolina, United States

Joseph Stavas, MD, MPH

• Cizman, Borut, ProKidney LLC, Winston-Salem, North Carolina, United States

Borut Cizman, MD

Background

Despite new treatments to delay disease progression in patients with diabetes and CKD, many patients continue to progress to kidney failure. In this phase 2 study (NCT05018416), we hypothesized that treatment with rilparencel (an autologous cell therapy prepared from cells obtained by kidney biopsy), in addition to standard of care, would be safe and preserve kidney function.

Methods

Adults with diabetes and eGFR (mL/min/1.73 m²) 20 to 50 were randomized 1:1 to two cohorts. Cohort (C)1 received 2 rilparencel injections (INJ), 3 mths apart, 1 in each kidney. C2 received 1 INJ and a 2nd INJ only upon a sustained decline in eGFR and/or increase in UACR. Participants (pts) were followed up to 18 mths after their last INJ. The primary efficacy end point was change in eGFR slope from the pre-INJ period to the period after the last INJ. The primary safety endpoint was the % of pts with procedure or rilparencel-related treatment emergent adverse events (TEAEs).

Results

53 pts were randomized and 49 received at least one INJ of rilparencel (n=24 in C1). Average age (SD) was 60 +/- 11yrs; 31% female; average eGFR (SD) was 33 +/- 10. In C1, annual eGFR slope in the pre-INJ period was -5.84 versus -1.27 in the period after the last INJ (difference between periods 4.57 (95% CI 1.95 to 7.18, p<0.001). In C2, annual eGFR slope in the pre-INJ period was -3.40 versus -1.77 in the period after the last INJ (difference between periods 1.70 (95% CI -0.24 to 3.63, p=0.085), see Figure. No interactions were observed in either C across multiple pre-defined baseline subgroups. Of 87 rilparencel INJ, procedure-related TEAEs occurred in 16 pts and rilparencel-related TEAEs occurred in 6 pts. Of these TEAEs, one pt experienced an INJ-related SAE (subcapsular renal hematoma). No product-related SAEs and no procedure- or product-related deaths were reported.

Conclusion

Bilateral kidney INJ of rilparencel preserves kidney function with an acceptable safety profile. A phase 3, randomized, sham-controlled study is ongoing.

Funding

• Commercial Support – ProKidney

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.202507jxq0jz