MSC for Occlusive Disease of the Kidney

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

4.1 Inclusion Criteria

• Are between ages 40 and 80 years old.
• Advanced vascular occlusive disease (atherosclerosis) affecting one or both kidneys: defined as a) loss of parenchymal volume and renal blood flow (measured by MDCT as previously described (17) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with MSC's.
• Have serum creatinine below 2.5 mg/dL
• Have no-contraindications to angiography: severe contrast allergy
• Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
• Ability to comply with protocol
• Competent and able to provide written informed consent

4.2 Exclusion Criteria

• Advanced CKD: Stage 5 (two kidney eGFR < 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis
• Clinically significant abnormalities on laboratory examination, including Bilirubin (> 2 x normal), platelets (<100 thousand), potassium (>5.5 mEq/L), and sodium (<130 mEq/L), ALT or AST more than 2 x normal, Prothrombin time (INR>1.4), Hemoglobin <10.0 g/dL.
• Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient.
• Specific exclusions:

• Clinical history of deep vein thrombosis within three months of MSC administration
• Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy)
• Active infection
• Reduced ejection fraction (below 30%)
• Evidence of hepatitis B,C, or HIV
• Diabetes treated with insulin and/or glucose lowering agents
• Anemia (Hgb<10 g/dL)
• Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (>2 x weekly)
• History of cancer including melanoma (with the exception of localized skin cancers)
• Investigational drug exposure within thirty (30) days of baseline
• Beck's depression score above 16
• Pregnant or breast feeding.
• History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity