Status:
COMPLETED
Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery
Lead Sponsor:
AlloCure Inc.
Collaborating Sponsors:
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Conditions:
Kidney Tubular Necrosis, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00733876
Start Date
August 1 2008
End Date
October 1 2013
Last Update
August 6 2014
Active Locations (2)
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1
Intermountain Medical Center
Murray, Utah, United States, 84157
2
St Mark's Hospital
Salt Lake City, Utah, United States, 84124