MSC for Occlusive Disease of the Kidney

Phase 1

Completed

• Conditions: Renovascular Hypertension; Ischemic Nephropathy; Atherosclerotic Renal Artery Stenosis
• Interventions: Drug: Arterial infusion of autologous mesenchymal stem cells

• Registration Number: NCT01840540
• Lead Sponsor: Mayo Clinic

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 Description

Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Primary Completion: 2014-03
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infusion of autologous mesenchymal stem cells	Arterial 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.

Primary Outcome Measures

Name	Time	Method
Renal blood flow and function in the treated kidneys.	2 years	Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.

Secondary Outcome Measures

Name	Time	Method
Level of kidney function.	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States