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Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease

Overview

Información sobre este estudio

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.  

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Latonya Hickson, M.D.

Cerrado para la inscripción

Contact information:

Beverly Tietje C.S.T.

(507)255-0401

Tietje.Beverly@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20438442

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