patient-derived stem cell therapy for diabetic kidney disease

Conditions: Diabetic Kidney Disease; Diabetic Nephropathies; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Chronic Kidney Disease; Diabetic Nephropathy Type 2; Kidney Failure; Kidney Insufficiency

Summary: the researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (msc) in patients with progressive diabetic kidney disease (dkd).

this is a single center, open-label dose-escalating study assessing safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose tissue-derived mesenchymal stem/stromal cells (msc) in 30 patients with progressive diabetic kidney disease (dkd). dkd will be defined as chronic kidney disease (ckd; estimated glomerular filtration rate; egfr\<60 ml/min/1.73m2) in the setting of diabetes mellitus (type 2; on anti-diabetes therapy) without overt etiologies of ckd beyond concomitant hypertension. progressive dkd will be considered as egfr 25-55 ml/min/1.73m2 with a) egfr decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated tangri 4-variable (age, sex, egfr, urinary albumin-creatinine ratio) kidney failure risk equation. fifteen subjects will be placed in one of two cell dosage arms in a parallel design with single-kidney msc administration at day 0 and month 3. subjects will be followed a total of 15 months from time of initial cell administration.

Eligibility criteria:
inclusion criteria: * diabetes mellitus (on anti-diabetes drug therapy) * age 45-75 years * egfr 25-55 ml/min/1.73m2 at time of consent with: a) egfr decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated tangri 4-variable (age, sex, egfr, urinary albumin-creatinine ratio) kidney failure risk equation https://kidneyfailurerisk.com/ * primary cause of kidney disease is diabetes without suspicion of concomitant kidney disease beyond hypertension * spot urine albumin:creatinine ≥30 mg/g unless on raas inhibition * ability to give informed consent exclusion criteria: * hemoglobin a1c≥11% * pregnancy * active malignancy * active immunosuppression therapy * kidney transplantation history * concomitant glomerulonephritis * nephrotic syndrome * solid organ transplantation history * autosomal dominant or recessive polycystic kidney disease * known renovascular disease * kidney failure (hemodialysis, peritoneal dialysis, or kidney transplantation) * active tobacco use * body weight \>150 kg or bmi\>50 * uncontrolled hypertension: systolic blood pressure (sbp) \>180 mmhg despite antihypertensive therapy * recent cardiovascular event (myocardial infarction, stroke, congestive heart failure within 6 months * evidence of hepatitis b or c, or hiv infection, chronic * anticoagulation therapy requiring heparin bridging for procedures. * history of methicillin-resistant staphylococcus aureus colonization * recent plastic, chemical or surgical manipulation of adipose tissue for cosmetic purposes within 6 months * inability to give informed consent * potentially unreliable subjects and those judged by the investigator to be unsuitable for the study

Keywords: mesenchymal stem cell mesencymal stromal cell stem cell regenerative medicine cell therapy rejuvenation