Trial | NCT00733876  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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.
Study Started
Aug 31
2008
Primary Completion
May 31
2010
Study Completion
Oct 31
2013
Last Update
Aug 06
2014
Estimate

Biological Multipotent Stromal Cells

Post-operative administration of MSC

Biological Administration of MSC

Dose escalation protocol

A Experimental

Criteria 

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
No Results Posted