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

This study is ongoing, but not recruiting participants.

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: September 21, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2008

Last Updated Date

September 21, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00733876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Tubular Necrosis, Acute

Intervention ^ICMJE

Biological: Multipotent Stromal Cells
Post-operative administration of MSC

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

Study Arm (s)

Experimental: A

Interventions:

Biological: Multipotent Stromal Cells
Biological: Administration of MSC

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00733876

Other Study ID Numbers ^ICMJE

NG-IMC001

Has Data Monitoring Committee

Yes

Responsible Party

AlloCure Inc.

Study Sponsor ^ICMJE

AlloCure Inc.

Collaborators ^ICMJE

Intermountain Health Care, Inc.
St Mark's Hospital Foundation

Investigators ^ICMJE

Study Director:

Christof Westenfelder, MD

AlloCure Inc.

Information Provided By

AlloCure Inc.

Verification Date

September 2011

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

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