Clinical Trial: MSC for Occlusive Disease of the Kidney

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis

Brief Summary: To determine the safety and toxicity of intra-arterial infused autologous adipose derived mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.

Detailed Summary: Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.
Sponsor: Mayo Clinic

Current Primary Outcome: Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ]

Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.


Original Primary Outcome: Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ]

Individual kidney blood flow, function and structure will be evaluated before and after MSC infusion. Toxicity data will be determined at each dose level.


Current Secondary Outcome: Level of kidney function. [ Time Frame: 2 years ]

Level of kidney function will be assessed as glomerular filtration rate by iothalamate clearance. Tissue oxygenation within each kidney will be measured by Blood Oxygen Level Dependent (BOLD) magnetic resonance.


Original Secondary Outcome: Level of kidney function and blood pressure. [ Time Frame: 2 years ]

Measure of glomerular filtration rate and oscillometrics blood pressure after 3 months.


Information By: Mayo Clinic

Dates:
Date Received: April 23, 2013
Date Started: April 2013
Date Completion: April 2017
Last Updated: October 8, 2015
Last Verified: October 2015