Abstract: SA-OR24
Renal Autologous Cell Therapy (REACT) for Type 2 Diabetic Kidney Disease: Preliminary Results with Renal Cortex Implantation
Session Information
- Diabetic Kidney Disease: Recent Advances
November 06, 2021 | Location: Simulive, Virtual Only
Abstract Time: 04:30 PM - 06:00 PM
Category: Diabetic Kidney Disease
- 602 Diabetic Kidney Disease: Clinical
Authors
- Stavas, Joseph, ProKidney, Raleigh, North Carolina, United States
- Ferris, Maria E., University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
- Silva, Arnold L., Boise Kidney and Hypertension, Boise, Idaho, United States
- Detwiler, Randal K., University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
- Coca, Steven G., Icahn School of Medicine at Mount Sinai, New York, New York, United States
- Burgner, Anna Marie, Vanderbilt University School of Medicine, Nashville, Tennessee, United States
- Segal, Mark S., University of Florida College of Medicine, Gainesville, Florida, United States
- Thajudeen, Bijin, Banner University Medical Center Tuscon, Tucson, Arizona, United States
- Filler, Guido, Western University, London, Ontario, Canada
- Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States
Background
Diabetic Kidney Disease (DKD) is the leading cause of kidney failure in the United States. REACT in preclinical trials demonstrated stability and improved kidney function without adverse effects. We present the 12 month findings of an ongoing Phase II multicenter randomized clinical trial (RCT) evaluating autologous homologous cell therapy on DKD progression in patients with stages 3a-4 DKD.
Methods
In this open label 1:1 RCT, 83 participants, 30-80 yrs, eGFR 20-50 ml/min/1.73m2 were randomized to either REACT or a control group of standard of care. All patients had a kidney biopsy with renal progenitor cell isolation and expansion by cGMP. The treated group received two cell implants into the kidney cortex at six-month intervals with CT guidance. The control received standard of care treatment (SoC) including maximized hypertension, diabetes and comorbidity management. The primary endpoint is change in eGFR. The current analysis compares the mean eGFR and UACR of completers in each group at 12 months.
Results
No differences in Hgb or HbA1c were present between groups at baseline or 12 months. Annualized mean eGFR increased and UACR decreased in the treatment group from time of first injection to 12 months (Table). Major bleeding complications occurred in 1% of each group following biopsy or cell injections. There were no cell-related adverse events.
Conclusion
Preliminary findings indicate implantation of progenitor REACT into the renal cortex in DKD is safe and improved annualized eGFR and UACR. Further data will follow completion of the study.
| Screening Data | Treated | Control | p value |
| Age (yrs) | 65.6±1.5 | 64.5±1.4 | 0.61 |
| Gender % (male) | 71.4 | 63.4 | |
| Caucasian % | 90.5 | 73.2 | |
| African American % | 4.8 | 12.2 | |
| Hemoglobin g/dL | 12.7±0.3 | 12.5±0.2 | 0.63 |
| HbA1c % | 7.2±0.2 | 7.1±0.2 | 0.59 |
| eGFR min/mL/1.73m2 | 34.2±1.3 | 31.48±1.3 | 0.67 |
| UACR (mg/gm) | 1143±29.4 | 1621±87.5 | 0.48 |
| 12-month Analysis | Treated | Control | p value |
| Hemoglobin | 11.8±0.75 | 12.1±0.41 | 0.66 |
| HbA1c | 7.5±0.33 | 7.05±0.35 | 0.30 |
| eGFR | 38.5±3.5 | 28.2±2.0 | 0.02 |
| UACR | 455±244 | 834±237 | 0.28 |
All Data: Mean ± Standard Error
Funding
- Commercial Support – ProKidney