MSC for Occlusive Disease of the Kidney
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-009298
NCT ID: NCT01840540
Sponsor Protocol Number: 12-009298
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Are between ages 40 and 80 years old
- 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) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with MSC's
- Have serum creatinine below 2.5 mg/d
- Have no-contraindications to angiography: severe contrast allergy
- Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Advanced CKD: Stage 5 (two kidney eGFR < 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis
- 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
- 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
- Specific exclusions:
- Clinical history of deep vein thrombosis within three months of MSC administration
- Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy)
- Active infection
- Reduced ejection fraction (below 30%)
- Evidence of hepatitis B,C, or HIV
- Diabetes treated with insulin and/or glucose lowering agents
- Anemia (Hgb<10 g/dL)
- Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (>2 x weekly)
- History of cancer including melanoma (with the exception of localized skin cancers)
- Investigational drug exposure within thirty (30) days of baseline
- Beck's depression score above 16
- Pregnant or breast feeding.
- History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.