Patient-derived Stem Cell Therapy for Diabetic Kidney Disease

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 30-50 ml/min/1.73m2 with
eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years (averaging -0.28
ml/min/month). 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.

Inclusion Criteria:

- Diabetes mellitus (on anti-diabetes drug therapy)

- Estimated glomerular filtration rate (eGFR) 30-50 ml/min/1.73m^2 with eGFR decline of
5 ml/min over 18 months or 10 ml/min over 3 years (either averaging
-0.28/ml/min/month) with no overt evidence of concomitant kidney disease beyond
hypertension

- Spot urine albumin:creatinine ≥30 mg/g unless on RAAS inhibition drugs

- 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