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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Kidney Tubular Necrosis, Acute	Biological: Multipotent Stromal Cells; Biological: Administration of MSC	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	August 2008
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: A	Biological: Multipotent Stromal Cells; Post-operative administration of MSC Biological: Administration of MSC; Dose escalation protocol

Outcome Measures

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Primary Outcome Measures :

1. Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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
• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
St Mark's Hospital
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

AlloCure Inc.

Intermountain Health Care, Inc.

St Mark's Hospital Foundation

Investigators

Study Director:	Christof Westenfelder, MD	AlloCure Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

Westenfelder C, Togel FE. Protective actions of administered mesenchymal stem cells in acute kidney injury: relevance to clinical trials. Kidney Int Suppl (2011). 2011 Sep;1(3):103-106. Review.

Responsible Party:	AlloCure Inc.
ClinicalTrials.gov Identifier:	NCT00733876 History of Changes
Other Study ID Numbers:	NG-IMC001
First Posted:	August 13, 2008
Last Update Posted:	August 6, 2014
Last Verified:	August 2014

Keywords provided by AlloCure Inc.:

Acute Renal Failure Cardiac Surgery Stem Cell

Additional relevant MeSH terms:

Acute Kidney Injury; Necrosis; Kidney Tubular Necrosis, Acute; Renal Insufficiency	Kidney Diseases; Urologic Diseases; Pathologic Processes