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Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

NCT02266394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-01-27

No results posted yet for this study

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

Interventions

DRUG

Mesenchymal stem cell

Intra-arterial infusion of the single-dose MSC

PROCEDURE

Mesenchymal stem cell delivery with stent placement

Intra-arterial stent placement after Mesenchymal stem cell infusion

Sponsors & Collaborators

  • University of Mississippi Medical Center

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Stephen C Textor, M.D. · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-21
Primary Completion
2020-09-25
Completion
2020-09-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266394 on ClinicalTrials.gov