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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.
Full description
Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.
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Inclusion and exclusion criteria
4.1 Inclusion Criteria
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:
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
Primary purpose
Allocation
Interventional model
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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