CompletedPhase 1

MSC for Occlusive Disease of the Kidney

United States6 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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%)

What they're measuring

Renal blood flow and function in the treated kidneys.

Timeframe: 2 years

Trial details

NCT IDNCT01840540

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Atherosclerotic Renal Artery Stenosis trials