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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733876
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : August 6, 2014
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Information provided by (Responsible Party):
AlloCure Inc.

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733876


Locations
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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
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Study Director: Christof Westenfelder, MD AlloCure Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AlloCure Inc.
ClinicalTrials.gov Identifier: NCT00733876    
Other Study ID Numbers: NG-IMC001
First Posted: August 13, 2008    Key Record Dates
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:
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Acute Kidney Injury
Kidney Tubular Necrosis, Acute
Necrosis
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Pathologic Processes