Stem Cell Therapy for Chronic Kidney Disease

Overview

Información sobre este estudio

The purpose of this study is to assess the safety, tolerability, optimal dosing, effectiveness signals reflecting kidney repair, and markers of mesenchymal stem cells (MSC) function that relate to response to allogenenic adipose tissue-derived MSC in patients with Chronic Kidney Disease (CKD).

 

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:

  • Age 30-80 years.
  • Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2.
  • Spot urine albumin:creatinine ≥ 30 mg/g unless on RAAS inhibition.
  • Ability to give informed consent.

Exclusion Criteria:

  • Hemoglobin A1c greater than or equal to 11% (in individuals with diabetes mellitus).
  • Anemia (hemoglobin less than 9 g/dL).
  • Body weight greater than 150 kg or BMI greater than 50.
  • Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control).
  • Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
  • Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
  • Active glomerulonephritis (glomerular diseases) include ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
  • Nephrotic syndrome defined as proteinuria greater than 3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema. Autosomal dominant or recessive polycystic kidney disease.
  • Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation).
  • Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily).
  • Kidney transplantation history.
  • Solid organ transplantation history.
  • Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias.
  • History of liver cirrhosis.
  • Chronic obstructive pulmonary disease or asthma requiring daily medication.
  • History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis).
  • Pregnancy.
  • Active malignancy.
  • Active infection.
  • History of hepatitis B or C (without cure), or HIV infection.
  • History of allergic reaction to cellular products (i.e., blood transfusions, platelets).
  • Active tobacco use.
  • Illicit drug use and excessive alcohol use.
  • Presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/ inflexible work schedule) that may interfere with the ability to complete all study procedures.
  • Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
  • Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies.
  • Inability to give informed consent.

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

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Latonya Hickson, M.D.

Cerrado para la inscripción

Contact information:

Latonya Hickson M.D.

(904) 956-8989

Hickson.Latonya@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20517304

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