Status:
TERMINATED
Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Regenerative Medicine Minnesota
Conditions:
Diabetic Kidney Disease
Diabetic Nephropathies
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
Brief 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/st...
Detailed 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 tiss...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03840343
Start Date
October 23 2019
End Date
August 4 2020
Last Update
August 17 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905