CompletedPhase 1

MSC for Occlusive Disease of the Kidney

United States6 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 (17) 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/dL
. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Renal blood flow and function in the treated kidneys.

Timeframe: 2 years

Trial details

NCT IDNCT01840540

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Atherosclerotic Renal Artery Stenosis trials