Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Overview

About this study

The purpose of this study is to assess the safety and tolerability of intra-arterially delivered mesenchymal stem/stromal cells (MSC) to a single kidney in one of two fixed doses at two time points in patients with progressive diabetic kidney disease. 

Diabetic kidney disease, also known as diabetic nephropathy, is the most common cause of chronic kidney disease and end-stage kidney failure requiring dialysis or kidney transplantation.  Regenerative, cell-based therapy applying MSCs holds promise to delay the progression of kidney disease in individuals with diabetes mellitus.  Our clinical trial will use MSCs processed from each study participant to test the ability of these cells to help repair kidney damages caused by diabetes.  Fat will be collected from the abdomen to produce the MSCs. A few months after the fat is collected, participants will then receive the stem cells into the kidney artery at two time points (Day 0 and Month 3). Participation in the trial will include approximately 4 on-site visits at Mayo Clinic in Rochester, Minnesota.  Some visits will require an overnight stay in the Clinical Research and Trials Unit. Several tests will be completed to assess the response to the stem cells, including two magnetic resonance imaging (MRI) scans. Participants will be followed for a total of 15 months after the first dose of stem cells are administered.  

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diabetes mellitus (on anti-diabetes drug therapy).
  • Age 40-80 years old.
  • Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2 at time of consent with:
    • eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years; or 
    • 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 diabetes without suspicion of concomitant kidney disease beyond hypertension.
  • Spot urine albumin:creatinine ≥ 30 mg/g unless on RAAS inhibition therapy.
  • 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).
  • 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).
  • Known hepatitis B or C, or HIV infection.
  • Anticoagulation therapy requiring heparin bridging for procedure.
  • Active tobacco use.
  • History of methicillin-resistant staphylococcus aureus colonization.
  • Recent plastic, chemical or surgical manipulation of adipose tissue for cosmetic purposes within 6 months.
  • Inability or unwilling to have magnetic resonance imaging (MRI) studies.
  • Inability to give informed consent.
  • Potentially unreliable subjects and those judged by the investigator to be unsuitable for the study.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Latonya Hickson, M.D.

Open for enrollment

Contact information:

Beverly Tietje C.S.T.

(507)255-0401

Tietje.Beverly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20438442

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