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
  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: 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 ] [ Designated as safety issue: Yes ]

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
Other Name: Multipotent Stromal Cells
Biological: Administration of MSC
Dose escalation protocol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AlloCure Inc.

Additional 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
Study First Received: August 11, 2008
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AlloCure Inc.:
Acute Renal Failure Cardiac Surgery Stem Cell

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Cortex Necrosis
Kidney Tubular Necrosis, Acute
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014