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Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

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ClinicalTrials.gov Identifier: NCT02266394
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
University of Mississippi Medical Center
University of Alabama at Birmingham
Information provided by (Responsible Party):
Stephen C. Textor, M.D., Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Renal Artery Stenosis Ischemic Nephropathy Renovascular Disease Chronic Kidney Disease Drug: Mesenchymal stem cell Procedure: Mesenchymal stem cell delivery with stent placement Phase 1

Detailed Description:
These studies include participation by human subjects using a 3-day inpatient CRU protocol at St. Mary's Hospital. Studies include formal measurement of blood and urinary markers of kidney function, BOLD MR and multidetector CT scanning. Forty-two non-diabetic patients between 40 and 80 years of any race or ethnicity will be recruited. All will have hypertension (defined as BP≥140/90 mmHg or ongoing antihypertensive drug therapy) but will have less than 180 mmHg to be included (with or without drug therapy). These subjects will be free of cardiovascular events within 3 months and will not have implanted electrical devices, such as a pacemaker or defibrillator. All patients will have identified large vessel renovascular disease (RVD) for Aims 1, 2 and 3. At least 10% of these subjects will be of African-American descent (self-identified) and recruited in collaboration with the University of Mississippi under the direction of Dr. Luis Juncos and the University of Alabama under the direction of Dr. David Calhoun. For completion of Aims 2 and 3, a three-day evaluation will be repeated between three and four months later, and ongoing safety and imaging studies will be performed up to 24 months after MSC administration. Participants in these protocols will undergo transvenous kidney biopsy under the direction of Drs. McKusick and Misra and their colleagues in Interventional Radiology. All subjects for these studies will complete the research plan at Mayo Clinic, Rochester, Minnesota.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypoxia and Inflammatory Injury in Human Renovascular Hypertension : Phase 1 Trial of Mesenchymal Stem Cell Therapy
Study Start Date : October 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Mesenchymal stem cell delivery
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
Intra-arterial infusion of the single-dose MSC
Other Name: Mesenchymal stem cell delivery

Active Comparator: Mesenchymal stem cell delivery with stent placement
To test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting.
Drug: Mesenchymal stem cell
Intra-arterial infusion of the single-dose MSC
Other Name: Mesenchymal stem cell delivery

Procedure: Mesenchymal stem cell delivery with stent placement
Intra-arterial stent placement after Mesenchymal stem cell infusion




Primary Outcome Measures :
  1. Change in Kidney function [ Time Frame: 3 months ]
    Renal Tissue oxygenation

  2. Safety of Mesenchymal stem cell infusion [ Time Frame: 2 years ]
    Number of patients with tissue injury markers


Secondary Outcome Measures :
  1. Decrease in Kidney inflammation [ Time Frame: 3 months ]
    Venous and tissue biomarkers of inflammation



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266394


Contacts
Contact: Beverly K Tietje, Associates 507-255-0401 tietje.beverly@mayo.edu

Locations
United States, Alabama
University of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: David Calhoun, M.D.         
Sub-Investigator: David Calhoun, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Beverly K Tietje, Associates    507-255-0401    tietje.beverly@mayo.edu   
Principal Investigator: Stephen C Textor, M.D.         
United States, Mississippi
University of Mississippi Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Luis Juncos, M.D.         
Sub-Investigator: Luis Juncos, M.D.         
Sponsors and Collaborators
Mayo Clinic
University of Mississippi Medical Center
University of Alabama at Birmingham
Investigators
Principal Investigator: Stephen C Textor, M.D. Mayo Clinic

Responsible Party: Stephen C. Textor, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02266394     History of Changes
Other Study ID Numbers: 14-002799
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Hypoxia
Renal Artery Obstruction
Hypertension, Renovascular
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
Arterial Occlusive Diseases
Hypertension, Renal