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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733876
First Posted: August 13, 2008
Last Update Posted: August 6, 2014
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.
Collaborators:
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Information provided by (Responsible Party):
AlloCure Inc.
  Purpose
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 Intervention Phase
Kidney Tubular Necrosis, Acute Biological: Multipotent Stromal Cells Biological: Administration of MSC Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AlloCure Inc.:

Primary Outcome Measures:
  • Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ]

Estimated Enrollment: 15
Study Start Date: August 2008
Study Completion Date: October 2013
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: Multipotent Stromal Cells
Post-operative administration of MSC
Biological: Administration of MSC
Dose escalation protocol

  Eligibility

Information from the National Library of Medicine

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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
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AlloCure Inc.
ClinicalTrials.gov Identifier: NCT00733876     History of Changes
Other Study ID Numbers: NG-IMC001
First Submitted: August 11, 2008
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