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A Study to Evaluate Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

Overview

Información sobre este estudio

Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Mesenchymal stem cells (MSC) are grown from a person's own fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney. This study is also being done to determine if the MSC infusion prior to percutaneous transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney blood flow and restoration of kidney function, as well as to assess the relationship between MSC dose and measures of kidney function.

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:

  • Creatinine < 2.2 mg/dL for Caucasian males, < 2.0 Caucasian females,< 2.4 African-American males, < 2.1 mg/dL African-American females.
  • Hypertension (Systolic BP > 155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g., hydrochlorothiazide, indapamide, metolazone) prior to study.
  • Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril).

Exclusion Criteria:

  • Diabetes requiring insulin or oral hypoglycemic medications.
  • Known allergy to furosemide or iodinated intravenous contrast.
  • Pregnancy.
  • Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months.
  • Cardiac ejection fraction less than 30%.
  • Evidence of hepatitis B or C, or HIV infection.
  • requirement for potentially nephrotoxic drugs; e.g., non-steroidal anti-inflammatory drugs.
  • Uncontrolled hypertension: SBP > 180 mm Hg, despite antihypertensive therapy.
  • Kidney transplant.
  • Pacemaker, implantable defibrillator or other contraindication to Magnetic resonance imaging.
  • Inability to comply with breath-hold for 30 seconds.
  • History of deep venous thrombosis within 3 months of enrollment.
  • Contraindications to renal biopsy including artificial valve requiring continuous anticoagulation.

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

Lilach Lerman, M.D., Ph.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-20141837

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