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

AlloCure Inc.2 sites in 1 country15 target enrollmentAugust 2008

ConditionsKidney Tubular Necrosis, Acute

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Kidney Tubular Necrosis, Acute
Sponsor: AlloCure Inc.
Enrollment: 15
Locations: 2
Primary Endpoint: Absence of MSC-specific Adverse or Serious Adverse Events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AlloCure Inc.

Responsible Party

Sponsor

Eligibility 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
•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.