Starvation ketoacidosis in patient with muscular dystrophy

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Conference Proceeding

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Publication Title

Am J Kidney Dis


Few treatment options are avaiable to delay renal replacement therapy for young patients with Type 2 Diabetes and eGFRs approaching End Stage Renal Disease. We describe an ongoing Phase II trial utilizing Neo-Kidney AugmentTM percutaneously injected into kidneys with Pre-Stage 5 T2DM CKD with intent to delay renal replacement therapy. REGEN-003 is a multi-center, non-randomized prospective, openlabel, single-arm study recruiting 10 patients (NCT03270956). Inclusion criteria include T2DM subjects age 30-65 years, eGFR 14 - 20 mL/min/1.73m3, and managed hypertension and HbA1c. Primary objective is safety of NKA injected in one recipient kidney and procedure and/or product related adverse events through 24 months. The method of renal NKA delivery is by real-time image guided percutaneous targeted injection into the subject's kidney with small caliber atraumatic needles in an outpatient setting with moderate sedation. NKA is composed of expanded autologous homologous selected renal cells obtained by kidney biopsy. Trial completion is expected early 2020. Of 6 enrolled subjects to date, mean age is 55.8 years, 66.7% female, 50% Non-Hispanic/Latino. Baseline eGFR, serum creatinine and ACR are shown below. All 6 subjects have undergone renal biopsy, 4 have received injections. There have been no cell product or injection related adverse events to date. 1 subject developed a post biopsy hematoma however successfully underwent NKA injection. Biomarkers measured Baseline values (S.D.) Number eGFR (mean) 22.27 mL/min (7.99) 5 sCreatinine (mean) 3.14 (0.47) 5 ACR (geometric mean) 1391.0 mg/g (911.1) 3 This active Phase 2 trial of pre-stage 5 DKD using novel imaged guided percutaneous targeted autologous homologous cell injection into the kidney offers potential for preservation of renal function and delay of renal replacement therapy.





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