A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease

Area of Science:

• Nephrology
• Regenerative Medicine
• Clinical Trials

Background:

• Diabetes and chronic kidney disease (CKD) pose significant risks for kidney failure despite existing treatments.
• Novel therapeutic strategies targeting multiple pathways are crucial for preserving kidney function in advanced CKD.

Purpose of the Study:

• To assess the efficacy and safety of rilparencel, an autologous cell therapy, in patients with diabetes and moderate-to-advanced CKD.
• To evaluate the impact of rilparencel injections on the estimated glomerular filtration rate (eGFR) slope.

Main Methods:

• A multi-center, randomized Phase 2 clinical trial (NCT05018416) involving participants with diabetes and eGFR between 20-50 mL/min/1.73 m2.
• Participants received either two rilparencel injections (Cohort 1) or one injection with a potential second dose (Cohort 2).
• Primary endpoints included change in eGFR slope and treatment-emergent adverse events (TEAEs) over 18 months.

Main Results:

• Rilparencel treatment was associated with a reduced rate of eGFR decline in both cohorts compared to the pre-injection period.
• Cohort 1 showed a significant difference in annual eGFR slope post-injection (4.57 mL/min/1.73 m2/year).
• The treatment demonstrated an acceptable safety profile, with no reported serious adverse events or deaths related to the procedure or product.

Conclusions:

• Bilateral kidney injection of rilparencel may offer a promising approach to preserve kidney function in patients with diabetes and CKD.
• The observed safety and efficacy data support the ongoing Phase 3 clinical trial to further evaluate rilparencel's therapeutic potential.