Kidney Tubular Necrosis, Acute
Conditions
Keywords
Acute Renal Failure Cardiac Surgery Stem Cell
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 undergoing on-pump cardiac surgery.
Interventions
BIOLOGICALMultipotent Stromal Cells
Post-operative administration of MSC
BIOLOGICALAdministration of MSC
Dose escalation protocol
Sponsors
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
AlloCure Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of MSC-specific Adverse or Serious Adverse Events | In hospital, monthly x 6, yearly x 3 |
Countries
United States
Outcome results
None listed