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

AlloCure

Status and phase

Completed

Phase 1

Conditions

Kidney Tubular Necrosis, Acute

Treatments

Biological: Multipotent Stromal Cells

Biological: Administration of MSC

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00733876

NG-IMC001

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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