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

Overview

About this study

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.

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:

  • 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.

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

Stephen Textor, M.D.

Closed for enrollment

Contact information:

Beverly Tietje C.S.T.

(507)255-0401

Tietje.Beverly@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20141837

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