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

Kidney Tubular Necrosis, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733876
• Other study ID #: NG-IMC001
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: August 5, 2014
• Start date: August 2008
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: AlloCure Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Tubular Necrosis, Acute

Intervention

Biological:
• Multipotent Stromal Cells
Post-operative administration of MSC
• Administration of MSC
Dose escalation protocol

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	St Mark's Hospital	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
AlloCure Inc.	Intermountain Health Care, Inc., St Mark's Hospital Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of MSC-specific Adverse or Serious Adverse Events		In hospital, monthly x 6, yearly x 3	Yes