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

This study has been completed.
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Information provided by (Responsible Party):
AlloCure Inc.
ClinicalTrials.gov Identifier:
NCT00733876
First received: August 11, 2008
Last updated: August 5, 2014
Last verified: August 2014

August 11, 2008
August 5, 2014
August 2008
May 2010   (final data collection date for primary outcome measure)
Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00733876 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Tubular Necrosis, Acute
  • Biological: Multipotent Stromal Cells
    Post-operative administration of MSC
    Other Name: Multipotent Stromal Cells
  • Biological: Administration of MSC
    Dose escalation protocol
Experimental: A
Interventions:
  • Biological: Multipotent Stromal Cells
  • Biological: Administration of MSC
Tögel FE, Westenfelder C. Kidney protection and regeneration following acute injury: progress through stem cell therapy. Am J Kidney Dis. 2012 Dec;60(6):1012-22. doi: 10.1053/j.ajkd.2012.08.034. Epub 2012 Oct 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2013
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733876
NG-IMC001
Yes
AlloCure Inc.
AlloCure Inc.
  • Intermountain Health Care, Inc.
  • St Mark's Hospital Foundation
Study Director: Christof Westenfelder, MD AlloCure Inc.
AlloCure Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP