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MSC for Occlusive Disease of the Kidney

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01840540
First Posted: April 25, 2013
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen C. Textor, M.D., Mayo Clinic
April 23, 2013
April 25, 2013
August 7, 2017
April 2013
March 2014   (Final data collection date for primary outcome measure)
Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ]
Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.
Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ]
Individual kidney blood flow, function and structure will be evaluated before and after MSC infusion. Toxicity data will be determined at each dose level.
Complete list of historical versions of study NCT01840540 on ClinicalTrials.gov Archive Site
Level of kidney function. [ Time Frame: 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.
Level of kidney function and blood pressure. [ Time Frame: 2 years ]
Measure of glomerular filtration rate and oscillometrics blood pressure after 3 months.
Blood pressure levels. [ Time Frame: 2 years ]
Blood pressure will be assessed by oscillometric measurement.
Not Provided
 
MSC for Occlusive Disease of the Kidney
Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis
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.
Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atherosclerotic Renal Artery Stenosis
  • Ischemic Nephropathy
  • Renovascular Hypertension
Drug: Arterial infusion of autologous mesenchymal stem cells
Other Name: MSC
Experimental: infusion of autologous mesenchymal stem cells
Patients will undergo a subcutaneous fat biopsy for expansion of mesenchymal stromal (stem) cells (MSC) in the Human Cell Therapy Laboratory. Patients will be admitted to the inpatient Clinical Research Unit of the Mayo Clinic Center for 3 days prior to treatment, for pre-infusion tests. Renal angiography will be performed to deliver a single intra-arterial dose of MSC's into one affected kidney. Patients will be observed for 24 hours for acute adverse events. Patients will have remote visits at 1 week, 4 weeks,8 weeks, and 6 months. At 3 months, patients will return for repeat evaluation of kidney function, blood flow and structural alterations within the clinical research unit at St. Mary's Hospital, Rochester, Minnesota. Thereafter, health assessment and blood draws will be repeated at 12 and 24 months with urinary cytology and MRI.
Intervention: Drug: Arterial infusion of autologous mesenchymal stem cells
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2017
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01840540
12-009298
No
Not Provided
Not Provided
Stephen C. Textor, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Stephen Textor, MD Mayo Clinic
Mayo Clinic
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP