Clinical trial NCT01840540: MSC for Occlusive Disease of the Kidney
Official title: Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerotic Renal Artery Stenosis
Ischemic Nephropathy
Renovascular Hypertension
Keywords: renal artery stenosis
renovascular hypertension
ischemic nephropathy
chronic kidney disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Renal blood flow and function in the treated kidneys.
timeFrame: 2 years
Secondary outcomes:
measure: Level of kidney function.
timeFrame: 2 years
Other outcomes:
measure: Blood pressure levels.
timeFrame: 2 years
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Textor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.