Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Mayo Clinic

Status and phase

Terminated

Phase 1

Conditions

Kidney Failure

Chronic Kidney Disease

Diabetes Mellitus, Type 1

Diabetic Nephropathies

Kidney Insufficiency

Diabetic Nephropathy Type 2

Diabetes Mellitus, Type 2

Diabetic Kidney Disease

Treatments

Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose

Biological: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose

Study type

Interventional

Funder types

Other

Identifiers

NCT03840343

RMM 091718 CT 001 (Other Grant/Funding Number)

18-002423

Details and patient eligibility

About

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).

Full description

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.

Enrollment

2 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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