A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

Author(s):  
2021 ◽  
pp. 1-6
Author(s):  
Joseph Stavas ◽  
Maria Diaz-Gonzalez de Ferris ◽  
Ashley Johns ◽  
Deepak Jain ◽  
Tim Bertram

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.


2012 ◽  
Vol 140 (5-6) ◽  
pp. 313-320 ◽  
Author(s):  
Aleksandra Paripovic ◽  
Natasa Stajic ◽  
Jovana Putnik ◽  
Radovan Bogdanovic

Introduction. Chronic kidney disease (CKD) is a significant cause of morbidity and mortality in paediatric population. Objective. The aim of the study was analysis of aetiology, staging and associated complications of CKD at the time of diagnosis. Methods. Data of 97 patients (56 boys) of average age 7.8?5.8 years, referred for the first time to the Institute for Mother and Child Healthcare ?Dr Vukan Cupic?, Belgrade in the period 1998- 2009, due to CKD, stage 2-5, were analysed. In each patient illness history was obtained, and physical examination, laboratory, X-ray and other investigations were performed according to the indications. CKD was classified according to the glomerular filtration rate into four grades: 2 - mild (60-90 ml/min/1.73 m2); 3 - moderate (30-60 ml/min/1.73 m2); 4 - advanced (15-30 ml/ min/1.73 m2); and 5 - terminal (<15 ml/min/1.73 m2). Results. The most frequent causes of CKD were congenital anomalies of the kidney and urinary tract (43.3%), followed by glomerular diseases (17.5%), hereditary kidney diseases (16.5%), metabolic diseases (7.2%) and other causes (15.5%). Mild CKD was found in 29.8%, moderate in 28.9%, advanced in 22.7%, and terminal in 18.6% children. Among patients with CKD stage 4 and 5, 75% of patients presented with acute renal failure, while 25% had earlier detected CKD (stage 1), but were not under regular follow-up. Associated complications included metabolic acidosis (63%), anaemia (60%), hypertension (42.3%), short stature (25.8%), renal osteodystrophy (13.4%) and cardiovascular diseases (7.2%). Conclusion. Congenital anomalies of the kidney and urinary tract are the leading cause of CKD in paediatric population. A significant proportion (41.3%) of patients had advanced and terminal CKD. In most patients CKD was diagnosed late and with associated complications.


2014 ◽  
Vol 29 (12) ◽  
pp. 2357-2364 ◽  
Author(s):  
Isabel G. Quirino ◽  
Cristiane S. Dias ◽  
Mariana A. Vasconcelos ◽  
Isabel V. Poggiali ◽  
Kerlane C. Gouvea ◽  
...  

Author(s):  
Teofana Otilia Bizerea ◽  
Anca Roxana Paul ◽  
Ramona Stroescu ◽  
Raluca Isac ◽  
Mihai Gafencu ◽  
...  

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