Atherosclerotic Renal Artery Stenosis, Ischemic Nephropathy, Renovascular Hypertension
Conditions
Keywords
renal artery stenosis, renovascular hypertension, ischemic nephropathy, chronic kidney disease
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.
Interventions
DRUGArterial infusion of autologous mesenchymal stem cells
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
4.1 Inclusion Criteria 1. Are between ages 40 and 80 years old. 2. 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. 3. Have serum creatinine below 2.5 mg/dL 4. Have no-contraindications to angiography: severe contrast allergy 5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia 6. Ability to comply with protocol 7. Competent and able to provide written informed consent 4.2
Exclusion criteria
1. Advanced CKD: Stage 5 (two kidney eGFR \< 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis 2. 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. 3. 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. 4. Specific exclusions: 1. Clinical history of deep vein thrombosis within three months of MSC administration 2. Uncontrolled hypertension (Systolic BP \>180 mmHg despite therapy) 3. Active infection 4. Reduced ejection fraction (below 30%) 5. Evidence of hepatitis B,C, or HIV 6. Diabetes treated with insulin and/or glucose lowering agents 7. Anemia (Hgb\<10 g/dL) 8. Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (\>2 x weekly) 5. History of cancer including melanoma (with the exception of localized skin cancers) 6. Investigational drug exposure within thirty (30) days of baseline 7. Beck's depression score above 16 8. Pregnant or breast feeding. 9. History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure levels. | 2 years | Blood pressure will be assessed by oscillometric measurement. |
Countries
United States
Outcome results
None listed