MSC for Occlusive Disease of the Kidney
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|ClinicalTrials.gov Identifier: NCT01840540|
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerotic Renal Artery Stenosis Ischemic Nephropathy Renovascular Hypertension||Drug: Arterial infusion of autologous mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2017|
Experimental: infusion of autologous mesenchymal stem cells
Patients will undergo a subcutaneous fat biopsy for expansion of mesenchymal stromal (stem) cells (MSC) in the Human Cell Therapy Laboratory. Patients will be admitted to the inpatient Clinical Research Unit of the Mayo Clinic Center for 3 days prior to treatment, for pre-infusion tests. Renal angiography will be performed to deliver a single intra-arterial dose of MSC's into one affected kidney. Patients will be observed for 24 hours for acute adverse events. Patients will have remote visits at 1 week, 4 weeks,8 weeks, and 6 months. At 3 months, patients will return for repeat evaluation of kidney function, blood flow and structural alterations within the clinical research unit at St. Mary's Hospital, Rochester, Minnesota. Thereafter, health assessment and blood draws will be repeated at 12 and 24 months with urinary cytology and MRI.
Drug: Arterial infusion of autologous mesenchymal stem cells
Other Name: MSC
- 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.
- 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.
- Blood pressure levels. [ Time Frame: 2 years ]Blood pressure will be assessed by oscillometric measurement.
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): NCT01840540
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Stephen Textor, MD||Mayo Clinic|