Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery

Completed · Phase 1

Conditions studied: Kidney Tubular Necrosis, Acute

In brief

The purpose of this trial is to determine if the administration of allogeneic MSCs at defined doses is safe in patients who are at high risk of developing significant Acute Kidney Injury (AKI) after undergoing on-pump cardiac surgery.

Key facts

Study ID

NCT00733876

Run by

AlloCure Inc.

People needed

15

Starts

2008-08-01

Expected to finish

2013-10-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented ischemic coronary heart and/or valvular heart disease:Acceptable candidate for elective CABG and/or Cardiac Valve Surgery
• Patients at high risk for post-op AKI:Age 18 or older if at high risk for post-op AKI because of underlying Diabetes mellitus (type I or II), CHF, COPD Chronic Kidney Disease (CKD) stage 1-4
• Patients at high risk for post-op AKI :age > 65 or combinations
• Patent femoral artery without aortic aneurysm
• Ability to give informed consent.

You may not qualify if…

• Presence of ongoing local or systemic infection
• Younger than 18
• Participation in another clinical trial
• Pregnancy
• Contraindication to general anesthesia
• Prisoner
• Dialysis patient (CKD-6) or patient with CKD-5
• History of malignancy except non-melanoma skin cancer
• Occluded Groin arteries
• Uncontrolled Diabetes mellitus (HbA1c > 10, history of diabetic ketoacidosis or osmolar coma within the last three months)
• Non-healing foot ulcers.
• Clinical evidence of severe peripheral vascular disease (ABI < 0.3)
• Coronary Angiogram < 7 days before surgery
• Inadequate pre-operative time to obtain baseline kidney function data due to urgent/emergent surgery
• Unstable myocardium (evolving myocardial infarction), cardiogenic shock

Where it is running

• Intermountain Medical Center — Murray, Utah, United States
• St Mark's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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