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

Phase 1

Completed

• Conditions: Kidney Tubular Necrosis, Acute
• Interventions: Biological: Multipotent Stromal Cells; Biological: Administration of MSC

• Registration Number: NCT00733876
• Lead Sponsor: AlloCure Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-13
• Primary Completion: 2010-05
• Study Completion: 2013-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Administration of MSC	-
A	Multipotent Stromal Cells	-

Primary Outcome Measures

Name	Time	Method
Absence of MSC-specific Adverse or Serious Adverse Events	In hospital, monthly x 6, yearly x 3

Trial Locations

Locations (2)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

St Mark's Hospital; 🇺🇸 Salt Lake City, Utah, United States