Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

NCT02266394 | Completed Phase 1 DMC

• 1 other identifier: 14-002799
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Renal Artery Stenosis; Ischemic Nephropathy; Renovascular Disease; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Change in Kidney function

  Renal Tissue oxygenation

  3 months

• Safety of Mesenchymal stem cell infusion

  Number of patients with tissue injury markers

  2 years

Secondary Outcomes (1)

• Decrease in Kidney inflammation

  3 months

Study Arms (2)

Mesenchymal stem cell delivery

ACTIVE COMPARATOR

To determine hemodynamic and immunologic changes associated with intra-renal delivery of adipose-derived MSC into human subjects with advanced RVD.

Drug: Mesenchymal stem cell

Mesenchymal stem cell delivery with stent placement

ACTIVE COMPARATOR

To test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting.

Drug: Mesenchymal stem cell; Procedure: Mesenchymal stem cell delivery with stent placement

Interventions

Mesenchymal stem cell DRUG

Intra-arterial infusion of the single-dose MSC

Also known as: Mesenchymal stem cell delivery

Mesenchymal stem cell delivery; Mesenchymal stem cell delivery with stent placement

Mesenchymal stem cell delivery with stent placement PROCEDURE

Intra-arterial stent placement after Mesenchymal stem cell infusion

Mesenchymal stem cell delivery with stent placement

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) .

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Mississippi Medical Center: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Lerman LO. Cell-based regenerative medicine for renovascular disease. Trends Mol Med. 2021 Sep;27(9):882-894. doi: 10.1016/j.molmed.2021.06.004. Epub 2021 Jun 25.

  PMID: 34183258 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Renal Artery Obstruction; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen C Textor, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: October 17, 2014
• Study Start: October 21, 2014
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)