Status:
COMPLETED
MSC for Occlusive Disease of the Kidney
Lead Sponsor:
Mayo Clinic
Conditions:
Atherosclerotic Renal Artery Stenosis
Ischemic Nephropathy
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01840540
Start Date
April 1 2013
End Date
April 1 2017
Last Update
August 7 2017
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905