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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01840540
Other study ID # 12-009298
Secondary ID
Status Completed
Phase Phase 1
First received April 23, 2013
Last updated August 4, 2017
Start date April 2013
Est. completion date April 2017

Study information

Verified date August 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 2017
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
Arterial infusion of autologous mesenchymal stem cells


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure levels. Blood pressure will be assessed by oscillometric measurement. 2 years
Primary Renal blood flow and function in the treated kidneys. Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion. 2 years
Secondary Level of kidney function. 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. 2 years
See also
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Completed NCT00006173 - Magnetic Resonance Imaging for Evaluating Kidney Function N/A