MSC for Occlusive Disease of the Kidney

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephen C. Textor, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01840540
First received: April 23, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Atherosclerotic Renal Artery Stenosis
Ischemic Nephropathy
Renovascular Hypertension
Drug: Arterial infusion of autologous mesenchymal stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.


Secondary Outcome Measures:
  • Level of kidney function. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Blood pressure levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Blood pressure will be assessed by oscillometric measurement.


Enrollment: 6
Study Start Date: April 2013
Estimated Study Completion Date: April 2017
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.  
Drug: Arterial infusion of autologous mesenchymal stem cells
Other Name: MSC

Detailed Description:

Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840540

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Stephen Textor, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Stephen C. Textor, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01840540     History of Changes
Other Study ID Numbers: 12-009298
Study First Received: April 23, 2013
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
renal artery stenosis
renovascular hypertension
ischemic nephropathy
chronic kidney disease

Additional relevant MeSH terms:
Hypertension
Constriction, Pathologic
Kidney Diseases
Renal Artery Obstruction
Hypertension, Renovascular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Urologic Diseases
Arterial Occlusive Diseases
Hypertension, Renal

ClinicalTrials.gov processed this record on October 16, 2014