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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Two MSC infusions of 2.5x10\^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
Two MSC infusions of 5.0x10\^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Adverse Events
The number of Adverse Events associated with MSC intervention per treatment arm
Time frame: Baseline through Month 15
Adverse Events
The percentage of Adverse Events associated with MSC intervention per treatment arm
Time frame: Baseline through Month 15
Kidney Function
Change in measured glomerular filtration rate (mGFR). Measured as mL/min/BSA
Time frame: baseline, month 6
Kidney Function
Change in estimated glomerular filtration rate (eGFR) slope. Measured as mL/min/1.73m\^2/month
Time frame: pretreatment, month 12
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