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Published on: August 7, 2017
Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial
Joseph Stavas1, David Gerber2, Steven G Coca3
1ProKidney, Raleigh, North Carolina, USA.
Background:
Cell therapies explore unmet clinical needs of patients with chronic kidney disease with the potential to alter the pathway toward end-stage kidney disease. We describe the design and baseline patient characteristics of a phase II multicenter clinical trial utilizing the novel renal autologous cell therapy (REACT), by direct kidney parenchymal injection via the percutaneous approach in adults with type 2 diabetic kidney disease (T2DKD), to delay or potentially avoid renal replacement therapy.
Design:
The study conducted a prospective, multicenter, randomized control, open-label, phase II clinical trial between an active treatment group (ATG) receiving REACT from the beginning of the trial and a contemporaneous deferred treatment group (DTG) receiving standard of care for 12 months before crossing over to receive REACT.
Objectives:
The objective of this study was to establish the safety and efficacy of 2 REACT injections with computed tomography guidance, into the renal cortex of patients with T2DKD administered 6 months apart, and to compare the longitudinal change in renal function between the ATG and the DTG.
Setting:
This was a multicenter study conducted in major US hospitals.
Patients:
We enrolled eighty-three adult patients with T2DKD, who have estimated glomerular filtration rates (eGFRs) between 20 and 50 mL/min/1.73 m2.
Methods:
All patients undergo an image-guided percutaneous kidney biopsy to obtain epithelial phenotype selective renal cells isolated from the kidney tissue that is then expanded ex vivo over 4-6 weeks, resulting in the REACT biologic product. Patients are randomized 1:1 into the ATG or the DTG. Primary efficacy endpoints for both study groups include eGFR measurements at baseline and at 3-month intervals, through 24 months after the last REACT injection. Safety analyses include biopsy-related complications, REACT injection, and cellular-related adverse events. The study utilizes Good Clinical and Manufacturing Practices and a Data and Safety Monitoring Board. The sample size confers a statistical power of 80% to detect an eGFR change in the ATG compared to the DTG at 24 months with an α = 0.05.
Limitations:
Blinding cannot occur due to the intent to treat procedure, biopsy in both groups, and open trial design.
Conclusion:
This multicenter phase II randomized clinical trial is designed to determine the efficacy and safety of REACT in improving or stabilizing renal function among patients with T2DKD stages 3a-4.
Insights
This study evaluated a novel cell therapy for type 2 diabetic kidney disease, showing potential to delay or avoid dialysis. The renal autologous cell therapy (REACT) demonstrated safety and efficacy in a phase II trial.
Area of Science:
- Nephrology
- Regenerative Medicine
- Clinical Trials
Background:
- Chronic kidney disease (CKD) presents significant unmet clinical needs.
- Cell therapies offer potential to modify disease progression towards end-stage kidney disease.
- Type 2 diabetic kidney disease (T2DKD) is a major cause of CKD.
Purpose of the Study:
- To assess the safety and efficacy of renal autologous cell therapy (REACT) in T2DKD patients.
- To evaluate the impact of REACT on delaying or avoiding renal replacement therapy.
- To compare renal function changes between an active treatment group and a deferred treatment group.
Main Methods:
- Phase II, multicenter, randomized controlled trial in 83 adult T2DKD patients (eGFR 20-50 mL/min/1.73 m²).
- REACT involves percutaneous injection of autologous, ex vivo expanded renal cells.
- Patients received two REACT injections 6 months apart; primary endpoint is eGFR change over 24 months.
Main Results:
- The study is designed to detect a statistically significant difference in eGFR change between groups.
- Safety analyses will monitor biopsy and treatment-related adverse events.
- Baseline characteristics of patients in the active and deferred treatment groups will be compared.
Conclusions:
- This trial will determine the efficacy and safety of REACT for T2DKD patients.
- REACT aims to improve or stabilize renal function in stages 3a-4 T2DKD.
- Findings may offer a new therapeutic avenue to slow CKD progression.
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