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Published on: August 7, 2017
Renal Autologous Cell Therapy to Stabilize Function in Diabetes-Related Chronic Kidney Disease: Corroboration of
Joseph Stavas1, Guido Filler2,3,4, Deepak Jain1
1ProKidney, LLC, Raleigh, North Carolina, USA.
Introduction:
Chronic kidney disease (CKD) is a worldwide disease without cure. Selected renal cells (SRCs) can augment kidney function in animal models. This study correlates the phenotypical characteristics of autologous homologous SRCs (formulated product called Renal Autologous Cell Therapy [REACT]) injected into patients' kidneys with advanced type 2 diabetes-related CKD (D-CKD) to clinical and laboratory findings.
Methods:
A total of 22 adults with type 2 D-CKD underwent a kidney biopsy followed by 2 subcortical injections of SRCs, 7 ± 3 months apart. There were 2 patients who had only 1 injection. We compared annualized estimated glomerular filtration rate (eGFR) slopes pre- and post-REACT injection using the 2009 CKD-EPI formula for serum creatinine (sCr) and the 2012 CKD-EPI Creatinine-Cystatin C equation and report clinical/laboratory changes. Fluorescent Activated Cell Sorting (FACS) Analysis for renal progenitor lineages in REACT and donor vascular endothelial growth factor A (VEGF-A) analysis were performed. Longitudinal parameter changes were analyzed with longitudinal linear mixed effects model.
Results:
At baseline, the mean diabetes duration was 18.4 ± 8.80 years, glycated hemoglobin (Hgb) was 7.0 ± 1.05, and eGFR was 40.3 ± 9.35 ml/min per 1.73 m2 using the 2012 CKD-EPI cystatin C and sCr formulas. The annualized eGFR slope (2012 CKD-EPI) was -4.63 ml/min per 1.73 m2 per year pre-injection and improved to -1.69 ml/min per 1.73 m2 per year post-injection (P = 0.015). There were 7 patients who had an eGFR slope of >0 ml/min per 1.73 m2 postinjection. SRCs were found to have cell markers of ureteric bud, mesenchyme cap, and podocyte sources and positive VEGF. There were 2 patients who had remote fatal adverse events determined as unrelated with the biopsies/injections or the REACT product.
Conclusion:
Our cell marker analysis suggests that SRCs may enable REACT to stabilize and improve kidney function, possibly halting type 2 D-CKD progression.
Insights
Renal Autologous Cell Therapy (REACT) using selected renal cells (SRCs) showed potential in stabilizing and improving kidney function for patients with type 2 diabetes-related chronic kidney disease (D-CKD). This innovative treatment may offer a new approach to halting D-CKD progression.
Area of Science:
- Nephrology
- Regenerative Medicine
- Cell Therapy
Background:
- Chronic kidney disease (CKD) affects millions globally with no definitive cure.
- Diabetes-related CKD (D-CKD) presents a significant clinical challenge.
- Selected renal cells (SRCs) have demonstrated potential in augmenting kidney function in preclinical models.
Purpose of the Study:
- To investigate the correlation between the phenotypical characteristics of autologous homologous SRCs (Renal Autologous Cell Therapy [REACT]) and clinical/laboratory findings in patients with advanced D-CKD.
- To assess the safety and efficacy of REACT in improving kidney function in D-CKD patients.
Main Methods:
- A cohort of 22 adults with type 2 D-CKD received subcortical injections of SRCs.
- Annualized estimated glomerular filtration rate (eGFR) slopes were compared pre- and post-REACT injection.
- Fluorescent Activated Cell Sorting (FACS) analysis was performed on SRCs, and vascular endothelial growth factor A (VEGF-A) levels were analyzed.
Main Results:
- The annualized eGFR slope significantly improved post-injection, from -4.63 to -1.69 ml/min per 1.73 m² per year (P = 0.015).
- Seven patients exhibited a positive eGFR slope (>0 ml/min per 1.73 m²) after treatment.
- SRCs displayed cell markers indicative of ureteric bud, mesenchyme cap, and podocyte origins, with positive VEGF expression.
Conclusions:
- Phenotypical analysis suggests SRCs within REACT may stabilize and improve kidney function in D-CKD.
- REACT holds promise as a therapeutic strategy to potentially halt the progression of type 2 D-CKD.
- The study indicates a favorable safety profile, with no determined adverse events related to the treatment.
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