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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Clinical Trial, Dose-escalating Intra-aortic Infusion of Allogeneic , Bone Marrow-derived Multipotent Stromal Cells to Prevent and Treat Post-operative Acute Kidney Injury in Patients Who Require On-pump Cardiac Surgery

Conditions
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Kidney Tubular Necrosis, Acute

Intervention / Treatment
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* Biological: Multipotent Stromal Cells
* Biological: Administration of MSC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Biological: Multipotent Stromal Cells<br>* Post-operative administration of MSC<br>Biological: Administration of MSC<br>* Dose escalation protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of MSC-specific Adverse or Serious Adverse Events |  | In hospital, monthly x 6, yearly x 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Renal Failure Cardiac Surgery Stem Cell