Impact of severe diabetic kidney disease on the clinical outcome of autologous cell therapy in people with diabetes and critical limb ischaemia

2019 ◽  
Vol 36 (9) ◽  
pp. 1133-1140 ◽  
Author(s):  
M. Dubský ◽  
A. Jirkovská ◽  
R. Bem ◽  
A. Němcová ◽  
V. Fejfarová ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Clinical Outcome ◽  
Cell Therapy ◽  
Diabetic Kidney Disease ◽  
Critical Limb Ischaemia ◽  
Limb Ischaemia ◽  
Diabetic Kidney ◽  
Autologous Cell ◽  
Autologous Cell Therapy

scholarly journals Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract

2021 ◽  
pp. 1-6
Author(s):  
Joseph Stavas ◽  
Maria Diaz-Gonzalez de Ferris ◽  
Ashley Johns ◽  
Deepak Jain ◽  
Tim Bertram
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Urinary Tract ◽  
Kidney Disease ◽  
Cell Therapy ◽  
Congenital Anomalies ◽  
Preliminary Analysis ◽  
Autologous Cell ◽  
Tissue Acquisition ◽  
Autologous Cell Therapy

Background: Advanced cell therapies with autologous, homologous cells show promise to affect reparative and restorative changes in the chronic kidney disease (CKD) nephron. We present our protocol and preliminary analysis of an IRB-approved, phase I single-group, open-label trial that tests the safety and efficacy of Renal Autologous Cell Therapy (REACT; NCT 04115345) in adults with congenital anomalies of the kidney and urinary tract (CAKUT). Methods: Adults with surgically corrected CAKUT and CKD stages 3 and 4 signed an informed consent and served as their “own” baseline control. REACT is an active biological ingredient acquired from a percutaneous tissue acquisition from the patient’s kidney cortex. The specimen undergoes a GMP-compliant manufacturing process that harvests the selected renal cells composed of progenitors for renal repair, followed by image-guided locoregional reinjection into the patient’s renal cortex. Participants receive 2 doses at 6-month intervals. Primary outcomes are stable renal function and stable/improved quality of life. Additional exploratory endpoints include the impact of REACT on blood pressure, vitamin D levels, hemoglobin, hematocrit and kidney volume by MRI analysis. Results: Four men and 1 woman were enrolled and underwent 5 cell injections. Their characteristics were as follows: mean 52.8 years (SD 17.7 years), 1 Hispanic, 4 non-Hispanic, and 5 white. There were no renal tissue acquisition, cell injection, or cell product-related complications at baseline. Conclusion: REACT is demonstrating feasibility and patient safety in preliminary analysis. Autologous cell therapy treatment has the potential to stabilize or improve renal function in CAKUT-associated CKD to delay or avert dialysis. Patient enrollment and follow-up are underway.

Clinical outcome of incident peritoneal dialysis patients with diabetic kidney disease

2018 ◽  
Vol 23 (3) ◽  
pp. 409-414 ◽  
Author(s):  
Kyoko Kishida ◽  
Yukio Maruyama ◽  
Kana Asari ◽  
Masatsugu Nakao ◽  
Nanae Matsuo ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Clinical Outcome ◽  
Diabetic Kidney Disease ◽  
Dialysis Patients ◽  
Diabetic Kidney

Abstract 252: Innovative Cell-therapy for Diabetic Kidney Disease (DKD)

2018 ◽  
Vol 38 (Suppl_1) ◽  
Author(s):  
Nabanita Kundu ◽  
Laureano Asico ◽  
Pedro Jose ◽  
Sabyasachi Sen
Keyword(s):  
Kidney Disease ◽  
Cell Therapy ◽  
Diabetic Kidney Disease ◽  
Diabetic Kidney

The Promise of Mesenchymal Stem Cell Therapy for Diabetic Kidney Disease

2016 ◽  
Vol 16 (5) ◽  
Author(s):  
Tomás P. Griffin ◽  
William Patrick Martin ◽  
Nahidul Islam ◽  
Timothy O’Brien ◽  
Matthew D. Griffin
Keyword(s):  
Stem Cell ◽  
Kidney Disease ◽  
Mesenchymal Stem Cell ◽  
Cell Therapy ◽  
Stem Cell Therapy ◽  
Diabetic Kidney Disease ◽  
Diabetic Kidney ◽  
Mesenchymal Stem Cell Therapy

scholarly journals P48 HUMAN CD362+ MESENCHYMAL STROMAL CELL THERAPY FOR DIABETIC KIDNEY DISEASE IN LEPR DB/DB MICE

2016 ◽  
Vol 1 (4) ◽  
pp. S22
Author(s):  
S.K. Devarapu ◽  
M. Darisipudi ◽  
S.J. Elliman ◽  
T.O. Brein ◽  
H.J. Anders
Keyword(s):  
Kidney Disease ◽  
Cell Therapy ◽  
Mesenchymal Stromal Cell ◽  
Stromal Cell ◽  
Diabetic Kidney Disease ◽  
Diabetic Kidney

scholarly journals Exploring macrophage cell therapy on Diabetic Kidney Disease

2018 ◽  
Vol 23 (2) ◽  
pp. 841-851 ◽  
Author(s):  
Roser Guiteras ◽  
Anna Sola ◽  
Maria Flaquer ◽  
Anna Manonelles ◽  
Georgina Hotter ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Cell Therapy ◽  
Diabetic Kidney Disease ◽  
Macrophage Cell ◽  
Diabetic Kidney

scholarly journals Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design

2022 ◽  
pp. 1-9
Author(s):  
Joseph Stavas ◽  
David Gerber ◽  
Steven G. Coca ◽  
Arnold L. Silva ◽  
Ashley Johns ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Function ◽  
Treatment Group ◽  
Kidney Disease ◽  
Phase Ii ◽  
Trial Design ◽  
Diabetic Kidney Disease ◽  
Autologous Cell ◽  
Autologous Cell Therapy

<b><i>Background:</i></b> 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. <b><i>Design:</i></b> 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. <b><i>Objectives:</i></b> 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. <b><i>Setting:</i></b> This was a multicenter study conducted in major US hospitals. <b><i>Patients:</i></b> We enrolled eighty-three adult patients with T2DKD, who have estimated glomerular filtration rates (eGFRs) between 20 and 50 mL/min/1.73 m<sup>2</sup>. <b><i>Methods:</i></b> 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. <b><i>Limitations:</i></b> Blinding cannot occur due to the intent to treat procedure, biopsy in both groups, and open trial design. <b><i>Conclusion:</i></b> 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.

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