Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Launched by MAYO CLINIC · Feb 11, 2019

Keywords

ClinConnect Summary

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 a...

Gender

ALL

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