Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

• Status: Completed
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: University of Alabama at Birmingham; University of Mississippi Medical Center

Criteria

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 (see text)

• 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